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Ardea Biosciences Reports Additional Positive Phase 2a Results for Lead HIV Candidate, RDEA806, Demonstrating Up to 1.9 Log Reduction in Plasma Viral Load with Once-Daily Dosing
Wednesday June 25, 8:00 am ET
- Once-daily dosing with enteric-coated tablet produced robust antiviral activity -
- RDEA806 was well tolerated during one week of dosing in HIV patients -
SAN DIEGO, June 25 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced additional positive results from its completed Phase 2a proof-of-concept monotherapy study of RDEA806, its novel investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in patients with human immunodeficiency virus (HIV).
These additional results demonstrated that once-daily dosing with the enteric-coated tablet formulation of RDEA806 resulted in significant reductions in plasma viral load that were consistent with results previously presented with twice-daily dosing of the capsule formulation in the same study. All dosing regimens tested in the study were well tolerated. Ardea's lead investigator plans to present the full data from this study at a medical conference later this year.
"RDEA806's robust antiviral potency, combined with its excellent tolerability profile in over 130 healthy volunteers and HIV-infected patients treated in clinical studies to-date, make RDEA806 a promising candidate for further investigation as a first-line agent for the treatment of HIV," said Dr. Graeme Moyle, Director of HIV Research, Chelsea and Westminster Hospital, and a lead investigator in the completed Phase 2a trial and planned Phase 2b study.
Phase 2a Clinical Trial Design & Top-line Results
The Phase 2a randomized, double-blind, placebo-controlled trial evaluated the antiviral activity, pharmacokinetics, safety and tolerability of once- and twice-daily oral dosing regimens of RDEA806 versus placebo in 48 HIV-positive patients who were naive to antiretroviral treatment. Nine out of 12 patients in each of four cohorts received RDEA806. The primary efficacy end point was the change from baseline in plasma viral load. Top-line results from all four cohorts showed the following:
-- The median reduction in plasma viral load at nadir was 1.9 - 2.1 log copies/ml (placebo adjusted) for all four treatment cohorts.
-- Patients receiving either 800 mg or 1000 mg once daily with the enteric-coated tablet formulation, and patients receiving 400 mg twice daily with the capsule formulation, experienced a 1.8 - 1.9 log median reduction in plasma viral load (adjusted for placebo) on Day 8; the 600 mg capsule formulation given once daily produced a 1.4 log median reduction (adjusted for placebo) at this time point.
-- There were no serious adverse events, ECG-related adverse events, or drug-related rash reported in any cohort. The incidence of CNS side effects was similar between drug and placebo. Administration of the highest dose on an empty stomach showed an increase in gastrointestinal side effects, but these effects were generally transient and mild.
-- There were no premature discontinuations in any cohort.
-- Based on the results generated in this trial, the doses planned for the Phase 2b program will be 600 mg, 800 mg and 1000 mg once daily with the enteric-coated tablet given with or without food.
"We are very pleased to announce the successful completion of the Phase 2a program with RDEA806," said Barry D. Quart, PharmD, Ardea's President and CEO. "Based on the excellent antiviral activity observed with once-daily dosing of the enteric-coated oral formulation, we plan to proceed in the third quarter of this year with a multi-national Phase 2b study comparing 600 mg, 800 mg and 1000 mg once daily doses of RDEA806 to efavirenz (SUSTIVA®) in first-line patients receiving background treatment with Truvada® (emtricitabine and tenofovir)."
About RDEA806
RDEA806 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) for the potential treatment of HIV infection. Based on preclinical and clinical studies to-date, Ardea believes that RDEA806 may have important competitive advantages. These include the potential for potent antiviral activity against a wide range of HIV viral isolates, including those that are resistant to efavirenz (Sustiva®) and other currently available NNRTIs; a high genetic barrier to resistance; no reproductive toxicity based on animal studies; the potential to be administered in a patient-friendly, oral dosing regimen; limited pharmacokinetic interactions with other drugs; and the ability to be co-formulated with other HIV antiviral drugs.
Ardea Biosciences Presents Preclinical Data on RDEA119 Demonstrating Favorable Anti-Inflammatory Profile for Potential Use in Ulcerative Colitis
Tuesday May 20, 6:30 pm ET
-- Phase 1 RDEA119 data expected in second half of 2008 --
-- Presentation at the Seventh Annual JMP Securities Research Conference on May 21st canceled; webcast of corporate update scheduled during Ardea's Annual Stockholder Meeting on May 22nd at 9:30 a.m. PT --
SAN DIEGO, May 20 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that data was presented on the Company's lead mitogen-activated ERK kinase (MEK) inhibitor, RDEA119, demonstrating potent activity in mouse models of colitis. An oral presentation of the data was given at Digestive Disease Week (DDW) 2008 in San Diego, California.
The MEK1/2 pathway is important in cell cycle regulation in inflammatory bowel disease, including ulcerative colitis and Crohn's disease. RDEA119 was shown to reduce damage to colonic tissue in two different mouse models of colitis, murine trinitrobenzene sulfonic acid (TNBS) colitis model and murine dextran sulfate sodium (DSS) colitis model. The beneficial effect observed equaled or exceeded that of sulfasalazine (Azulfidine®), a therapy commonly used for acute and maintenance treatment of ulcerative colitis.
"Despite the existing treatments, there are still significant unmet medical needs for inflammatory bowel disease. Blocking the MEK1/2 pathway appears to be a promising strategy in the ongoing search for a new generation of therapies aimed to treat ulcerative colitis and Crohn's disease," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "These data further support the potential use of orally administered MEK inhibitors, such as RDEA119, for the treatment of inflammatory diseases."
To support the development of RDEA119 in inflammatory diseases, a Phase 1 study in normal healthy volunteers is ongoing in which the Company is evaluating the pharmacokinetics, safety and tolerability of RDEA119, as well as its ability to inhibit inflammatory cytokines. Preliminary Phase 1 data have demonstrated that RDEA119 has a long half-life and favorable pharmacokinetic properties, allowing for once daily oral dosing. In addition, RDEA119 is currently in a Phase 1 study in advanced cancer patients. The doses being evaluated in the Phase 1 study in advanced cancer patients have achieved systemic exposure consistent with active doses in animal models of human tumors, without drug-related toxicity.
The presentation is available on the Company website (http://www.ardeabio.com/) under the title "RDEA119, a Potent and Highly Selective MEK Inhibitor Ameliorates Murine Colitis."
Corporate Update at Annual Stockholder Meeting
Ardea will provide a corporate update at its Annual Stockholder Meeting. The presentation is scheduled for Thursday, May 22nd, at 9:30 a.m. Pacific Time. To participate by telephone, please dial 877-440-5804 from the U.S. and Canada or +1-719-325-4854 for international callers. In addition, the live conference call is being webcast and can be accessed on the "News & Events" page of the Company's website at http://www.ardeabio.com. A replay will also be available on Ardea's website for 14 days and by telephone through May 31, 2008. For the telephonic replay, please dial 888-203-1112 in the U.S. and Canada or +1-719-457-0820 for international callers, and enter passcode 9342491 when prompted.
Ardea Biosciences Identifies Lead Development Candidate for Gout, RDEA594
Monday May 19, 8:00 am ET
- RDEA594 Data to Be Presented at the 2008 Annual European Congress of Rheumatology Organized by the European League Against Rheumatism (EULAR) -
- Initiation of Phase 1 Human Study of RDEA594 Planned in Second Half of 2008 -
SAN DIEGO, May 19 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced the identification of its lead development candidate for the treatment of patients with gout, RDEA594. Gout is a painful and debilitating disease that is caused by abnormally elevated levels of uric acid in the blood stream. RDEA594 is a major metabolite in both humans and animals of RDEA806, the Company's lead human immunodeficiency virus (HIV) development candidate. RDEA594 does not have significant antiviral activity, but is believed to be responsible for essentially all of the uric acid lowering effects seen with RDEA806. Robust uric acid-lowering effects have been observed following administration of RDEA806 in Phase 1 and Phase 2 clinical trials that included over 100 subjects.
Based on extensive in vitro and in vivo experiments, the Company believes it has elucidated the mechanism by which RDEA594 lowers serum uric acid levels. RDEA594 exhibits a concentration-dependent inhibitory effect on the URAT1 transporter-mediated uptake of uric acid ex vivo and increases uric acid excretion in animal models. These effects are believed to result in the lowering of serum uric acid observed with RDEA806. URAT1 is a specific urate transporter expressed in the kidney responsible for regulation of uric acid levels, and is a validated target for treatment of hyperuricemia and gout.
"Gout represents a major medical challenge in the United States and throughout the world, with millions of people affected by this debilitating condition," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "With the designation of RDEA594 as our clinical candidate for the treatment of gout, we now expect to have five novel candidates in clinical testing during the second half of 2008, positioning us with the potential to have a broad-based, late-stage pipeline in 2009. This finding also allows us to focus our future development efforts with RDEA806 on the treatment of HIV."
The Company plans to initiate a Phase 1 clinical study of RDEA594 in the second half of this year. As previously announced, the Company also plans to conduct a Phase 2 proof-of-concept clinical study in patients with gout, to confirm RDEA594's activity in the target population using its prodrug, RDEA806. This study is on track to be initiated in the second quarter of this year.
The EULAR presentation details are as follows:
Date/Time: Thursday, June 12, 2008 from 11:45 a.m. - 1:30 p.m. CEST
Title: Safety and Uric Acid Lowering Effect in Humans Following Multiple
Doses of RDEA806, A Novel Prodrug for the Potential Treatment of
Hyperuricemia
Location: Le Palais de Congres de Paris - Level 1 (Abstract # THU0356)
Date/Time: Thursday, June 12, 2008 from 11:45 a.m. - 1:30 p.m. CEST
Title: Mode of Action of RDEA594 as a Uric Acid Lowering Agent in Humans
Following Multiple Doses of its Prodrug, RDEA806
Location: Le Palais de Congres de Paris - Level 1 (Abstract # THU0357)
Ardea Biosciences to Present Data on Lead MEK Inhibitor, RDEA119, at Digestive Disease Week 2008
Wednesday May 14, 4:31 pm ET
SAN DIEGO, May 14 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that preclinical data will be presented on the Company's lead mitogen-activated ERK kinase (MEK) inhibitor, RDEA119, at Digestive Disease Week (DDW) 2008 in San Diego.
The oral presentation details are as follows:
Date/Time: Tuesday, May 20, 2008 at 3:30 p.m. Pacific Time
Abstract Title: RDEA119, a Potent and Highly Selective MEK Inhibitor
Ameliorates Murine Colitis
Session Title: Novel Therapeutic Agents in Experimental Colitis
Location: 28DE: San Diego Convention Center
About Ardea Biosciences
Ardea Biosciences, Inc. of San Diego, California, is a biotechnology company focused on the discovery and development of small-molecule therapeutics for the treatment of HIV, cancer and inflammatory diseases, including gout. We have four drug candidates in clinical trials and several others in preclinical development and discovery. Our most advanced drug candidate is RDEA806, a non-nucleoside reverse transcriptase inhibitor (NNRTI), which is in a Phase 2a study for the treatment of HIV. We have evaluated our second generation NNRTI, RDEA427, for the treatment of HIV in a human micro-dose pharmacokinetic study and have selected it as a development candidate. We are also investigating RDEA806 for the treatment of gout. We are evaluating our lead MEK inhibitor, RDEA119, in a Phase 1 study in advanced cancer patients, as well as in a Phase 1 study in normal healthy volunteers for the treatment of inflammatory diseases. We have evaluated our second generation MEK inhibitor, RDEA436, for the treatment of cancer and inflammatory diseases in a human micro-dose pharmacokinetic study, and have selected it as a development candidate. In addition to the foregoing clinical programs, we are investigating other drug candidates in earlier stages of preclinical development and discovery.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: sufficiency of cash resources and our goals, including the expected properties and benefits of RDEA806, RDEA427, RDEA119, RDEA436 and our other compounds and the results of preclinical, clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcome of preclinical and clinical studies, risks related to regulatory approvals, delays in commencement of preclinical and clinical studies, and costs associated with internal development and business development activities. These and other risks and uncertainties are described more fully in our most recently filed SEC documents, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Ardea Biosciences Appoints John W. Beck Chief Financial Officer, Announces Clinical Development Progress and Reports First Quarter 2008 Financial Results
Friday May 9, 8:00 am ET
SAN DIEGO, May 9 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News), a company focused on the discovery and development of small- molecule therapeutics for the treatment of HIV, cancer and inflammatory diseases, including gout, today announced that John W. Beck has been appointed Senior Vice President, Finance and Operations and Chief Financial Officer effective May 27, 2008. He will resign from our board of directors shortly thereafter. The Company also reported recent accomplishments and financial results for the first quarter ended March 31, 2008.
Appointment of John W. Beck as Chief Financial Officer
"We are extremely pleased to welcome John Beck as the new Chief Financial Officer of Ardea," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "John has served as a member of our board of directors since June 2007. He is a proven leader with more than 20 years of financial management experience. We believe that he will play an important role in our ongoing success."
Mr. Beck joins Ardea Biosciences from Metabasis Therapeutics, Inc., which he co-founded in 1999 and where he served most recently as Senior Vice President of Finance, Chief Financial Officer and Treasurer. Prior to Metabasis, he served as Director of Finance of Neurocrine Biosciences, Inc., where he played an important role in Neurocrine's 1996 initial public offering. Prior to joining Neurocrine, Mr. Beck held financial management positions at various high technology and financial services companies, including General Dynamics and Ernst and Young LLP. Mr. Beck received a B.A. in accounting from the University of Washington and also holds a Th.B. in theology from a Seattle, Washington-based seminary. Mr. Beck is a licensed (inactive status) certified public accountant in the state of California and is a member of the American Institute of Certified Public Accountants and the Association of Bioscience Financial Officers.
Recent Accomplishments
In the first quarter of 2008, we continued to progress our development pipeline in all three therapeutic areas of focus, including:
-- Announced positive preliminary results for RDEA806, our lead non-
nucleoside reverse transcriptase inhibitor (NNRTI), in a Phase 2a
monotherapy study in patients with human-immunodeficiency virus (HIV),
demonstrating an up to 2.0 log placebo-adjusted reduction in plasma
viral load after seven days of treatment;
-- Completed a first-in-human micro-dosing study of our second generation
NNRTI, RDEA427, and selected it as a development candidate;
-- Completed a first-in-human micro-dosing study of our second generation
MEK inhibitor, RDEA436, and selected it as a development candidate;
-- Presented preclinical data demonstrating potent activity and favorable
resistance profiles for our next generation NNRTI family of compounds
against HIV at the 15th Annual Conference on Retroviruses and
Opportunistic Infections (CROI) and the 21st International Conference
on Antiviral Research (ICAR);
-- Presented preclinical data demonstrating the potent activity and
favorable pharmacokinetic profile of our mitogen-activated ERK kinase
(MEK) inhibitor family of compounds in the treatment of cancer,
preliminary Phase 1 data demonstrating the potential for once-daily
oral dosing of RDEA119, our lead MEK inhibitor, and first-in-human
micro-dose data for RDEA436, at the American Association for Cancer
Research (AACR);
-- Established two scientific advisory boards to guide the HIV and
inflammation programs; and
-- Relocated our corporate headquarters and research laboratories to San
Diego's biotechnology corridor.
2008 1st Quarter Financial Results:
http://biz.yahoo.com/prnews/080509/aqf045.html?.v=46
Ardea Biosciences Presents Data Demonstrating Favorable Pharmacokinetics and Efficacy for Mitogen-Activated ERK Kinase (MEK) Inhibitors
Tuesday April 15, 4:00 pm ET
- Lead MEK inhibitor, RDEA119, demonstrates potential for once daily oral dosing in preliminary Phase 1 results -
- Next generation MEK inhibitor, RDEA436, to enter Phase 1 trials second half of 2008 -
SAN DIEGO, April 15 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that data was presented demonstrating the potent activity and favorable pharmacokinetic profile of the Company's mitogen-activated ERK kinase (MEK) inhibitor family of compounds in the treatment of cancerous tumors.
The data were presented at the American Association for Cancer Research (AACR) annual meeting in San Diego.
The data showed that RDEA119 and RDEA436 are potent inhibitors of MEK1/2, an important step in cell cycle regulation. Both compounds suppress tumor cell growth in vitro and in vivo, have significant anti-inflammatory activity, and have limited potential for central nervous system (CNS) toxicity, a problem for other members of this class. RDEA119 is currently in Phase 1 clinical studies in advanced cancer patients and healthy volunteers for assessment of its ability to inhibit inflammatory cytokines. Preliminary Phase 1 data have demonstrated that RDEA119 has a long half-life and favorable pharmacokinetic properties, allowing for once daily oral dosing. In addition, the doses being evaluated in the Phase 1 study have achieved systemic exposure consistent with active doses in animal models of human tumors, without drug-related toxicity. Data from a human micro-dose trial, produced by Vitalea Science, Inc. using Accelerator Mass Spectrometry (AMS) technology, demonstrated that RDEA436 also has a long half-life and favorable pharmacokinetic properties.
"MEK inhibitors may have broad utility in the treatment of human cancers and inflammatory diseases. We are pleased to have two compounds in this class, both with excellent preclinical profiles and promising human pharmacokinetics, moving forward in clinical development," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "We constantly strive to diminish the inherent risk of drug development by having multiple compounds, from structurally different chemical classes, moving through development and we are excited to complete Phase 1 testing of our lead MEK inhibitor, RDEA119, and progress RDEA436 into Phase 1 clinical testing, in the second half of 2008."
The posters are available on the Company website (http://www.ardeabio.com/) under the titles "RDEA119, a Potent and Highly Specific MEK Inhibitor is Efficacious in Mouse Tumor Xenograft Studies" and "RDEA436, a Novel MEK Inhibitor with Favorable Pharmacokinetic Properties."
About RDEA119 and RDEA436
RDEA119 and RDEA436, non-ATP competitive, highly-selective MEK inhibitors for the treatment of cancer and inflammatory diseases, are two of the compounds from Ardea's MEK inhibitor research and development program. RDEA119 has shown potential as a potent and selective inhibitor of MEK, which is believed to play an important role in cancer cell proliferation, apoptosis and metastasis. Preclinical and clinical results suggest that RDEA119 has favorable properties, including oral dosing, excellent selectivity and limited retention in the brain, which, in turn, may result in a reduced risk of central nervous system (CNS) side effects. Preclinical data shows that RDEA436 is a potent in vitro and in vivo inhibitor of MEK, has favorable pharmacokinetic properties with low CNS penetration and a long half-life in a human micro-dose study indicating the potential for once daily dosing in humans.
Ardea Presents Preclinical Data on Novel Next Generation Non-Nucleoside Reverse Transcriptase Inhibitors Demonstrating Potent Anti-HIV Activity Against Resistant Viruses
Monday April 14, 8:00 am ET
-- Lead NNRTI RDEA806 to begin Phase 2b trial in the second quarter of 2008 --
MONTREAL and SAN DIEGO, April 14 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that preclinical data was presented on the Company's next generation non-nucleoside reverse transcriptase inhibitor (NNRTI) family of compounds demonstrating potent activity against the human-immunodeficiency virus (HIV), including NNRTI- resistant strains, with the potential for improved performance over current NNRTIs.
The data were presented at the 21st International Conference on Antiviral Research (ICAR) in Montreal, Quebec, Canada.
The compounds in this series are potent against both wild-type and the most common NNRTI-resistant viruses and are more active than efavirenz (Sustiva®, BMS) and nevirapine (Viramune®, Boehringer-Ingelheim) against a broad panel of NNRTI-resistant clinical isolates.
"Safer, better tolerated NNRTIs that also work against viruses resistant to the most widely used NNRTIs, are needed to expand the armamentarium," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "Our lead NNRTI, RDEA806, has shown the potential to match this profile and we are preparing to progress it into a Phase 2b trial later this quarter. An important part of our business strategy is to progress an additional next generation NNRTI, from the structurally novel series presented today, into Phase 1 later this year."
The poster is available on the Company website (http://www.ardeabio.com) under the title, "A Novel NNRTI Class with Potent Anti-HIV Activity against NNRTI-Resistant Viruses."
About RDEA806
RDEA806 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) for the potential treatment of HIV infection. Based on preclinical and clinical studies to-date, Ardea believes that RDEA806 may have important competitive advantages. These include the potential for potent antiviral activity against a wide range of HIV viral isolates, including those that are resistant to efavirenz (SUSTIVA®) and other currently available NNRTIs; a high genetic barrier to resistance; the potential to be administered in a patient-friendly, oral dosing regimen; limited pharmacokinetic interactions with other drugs; and the ability to be co-formulated with other HIV antiviral drugs.
Ardea to Present Data on HIV Non-Nucleoside Reverse Transcriptase Inhibitor and Two MEK Inhibitors at Upcoming Medical Conferences
Monday April 7, 8:00 am ET
SAN DIEGO, April 7, 2008 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that data will be presented on its second generation non-nucleoside reverse transcriptase inhibitors (NNRTIs), at the 21st International Conference on Antiviral Research (ICAR). Additionally, data on two of the Company's mitogen-activated ERK kinase (MEK) inhibitors, RDEA119 and RDEA436, will be presented at the American Association for Cancer Research (AACR) annual meeting.
The presentation details are as follows:
-- 21st ICAR in Montreal, Quebec, Canada
Date/Time: Monday, April 14, 2008 at 4:00 p.m. Eastern Time
Title: A Novel NNRTI Class with Potent Anti-HIV Activity against
NNRTI-Resistant Viruses
Location: Poster Session 1 (Poster #80)
-- AACR Annual Meeting in San Diego, California
Date/Time: Tuesday, April 15, 2008 at 1:00 p.m. Pacific Time
Title: RDEA119, a Potent and Highly Specific MEK Inhibitor is
Efficacious in Mouse Tumor Xenograft Studies
Location: Poster Session 32 (Poster #4878), Exhibit Hall B-F
Date/Time: Tuesday, April 15, 2008 at 1:00 p.m. Pacific Time
Title: RDEA436, a Novel MEK Inhibitor with Favorable
Pharmacokinetic Properties
Location: Poster Session 32 (Poster #4895), Exhibit Hall B-F
Ardea Biosciences Reports Progress of Clinical Development Programs; Provides 2008 Outlook; Announces 2007 Financial Results and Provides 2008 Financial Guidance
Monday March 24, 8:00 am ET
SAN DIEGO, March 24 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News), a company focused on the discovery and development of small- molecule therapeutics for the treatment of HIV, cancer and inflammatory diseases, including gout, today reported significant accomplishments in 2007, provided key milestones in 2008 for its clinical development programs, announced 2007 fourth quarter and full-year financial results and provided financial guidance for 2008.
"During 2007, we made significant strides in establishing a solid corporate foundation on which our future successes will be built," said Barry D. Quart, PharmD, Ardea Biosciences' President and CEO. "We assembled a proven management team and a group of key expert advisors; we added depth to our pipeline through the discovery of an exciting new product opportunity in gout; and we continued to make progress with our HIV, cancer and inflammatory disease programs."
Recent Accomplishments
-- Reported positive preliminary data from a Phase 2a proof-of-concept
trial of RDEA806 in patients with HIV;
-- Initiated a new clinical development program, stemming from our
RDEA806 research, directed toward the treatment of gout;
-- Initiated a Phase 1 trial of RDEA119 in patients with advanced cancer;
-- Completed a first-in-human micro-dosing study of RDEA436, a second
generation MEK inhibitor for the treatment of cancer and inflammatory
diseases and, based on an encouraging pharmacokinetic profile,
nominated it as a development candidate;
-- Completed a $40 million private placement;
-- Established two scientific advisory boards to guide the inflammatory
disease and HIV programs;
-- Presented preclinical data demonstrating potent activity and favorable
resistance profiles for our non-nucleoside reverse transcriptase
inhibitor (NNRTI) family of compounds against HIV at the 15th Annual
Conference on Retroviruses and Opportunistic Infections (CROI);
-- Presented favorable anti-tumor preclinical data on RDEA119 at the 2007
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics; and
-- Relocated our corporate headquarters and research laboratories to San
Diego's biotechnology corridor.
2008 Anticipated Key Program Milestones
In 2008, Ardea anticipates accomplishing the following milestones:
HIV
-- Initiate a Phase 2b trial of RDEA806 in patients with HIV in the
second quarter of 2008;
-- Complete a first-in-human micro-dosing study of our second generation
NNRTI, RDEA427, in the first quarter of 2008;
-- Initiate a Phase 1 trial of RDEA427 in the second half of 2008; and
-- Present the full results of our Phase 2a proof-of-concept study of
RDEA806 at a scientific conference in the second half of 2008.
Gout/Inflammation
-- Initiate a Phase 2 dose-finding trial for the treatment of gout in
the second quarter of 2008 with results expected in the second half
of 2008; and
-- Initiate a Phase 2a trial with RDEA119 for the treatment of
inflammatory disease in the second quarter of 2008.
Cancer
-- Complete and report data from the Phase 1 trial of RDEA119 in
patients with advanced cancer in the second half of 2008;
-- Initiate Phase 2 trials of RDEA119 in combination with other anti
cancer agents in the second half of 2008; and
-- Initiate a Phase 1 trial of our second generation MEK inhibitor in
the second half of 2008.
2007 Financial Results
Ardea's 2007 year-end cash balance was $66.2 million, compared to $48.7 million for the 2006 year-end cash balance. The December 31, 2007 cash balance includes net proceeds of $37.2 million from a private placement of common stock in December 2007.
The net loss for the fourth quarter 2007 was $9.1 million, or $0.86 per share, compared to a net loss for the same period in 2006 of $0.5 million, or $0.05 per share. The net loss for the year ended December 31, 2007 was $25.3 million, or $2.55 per share, compared to a net loss for the year ended December 31, 2006 of $0.6 million, or $0.07 per share. The net loss for the quarter and full-year ended December 31, 2007 included non-cash stock-based compensation expense of $0.6 million, or $0.05 per share, and $1.4 million, or $0.14 per share, respectively. The difference between the Company's 2007 and 2006 results reflects the rebuilding of its operations combined with the advancement and expansion of its preclinical and clinical drug development programs.
Revenues for the fourth quarter of 2007 were $0.3 million, compared to zero for the same period in 2006. Revenues for the full-year 2007 were $3.1 million compared to zero for 2006. The increase is due to research performed by the Company as part of a master services agreement with Valeant.
2008 Financial Guidance
On December 31, 2007, the Company had a total of $66.2 million in cash, cash equivalents and short-term investments. Excluding any funds that Ardea may receive from future business development activities, the Company anticipates 2008 net cash usage to be between $45 million and $50 million.
Ardea HIV Drug Meeting Study Goals
Monday March 17, 5:40 pm ET
Ardea Biosciences' Developing HIV Treatment Is Meeting Midstage Study Goals
SAN DIEGO (AP) -- Ardea Biosciences Inc. said Monday its developing HIV treatment is meeting goals in a midstage clinical trial and the program is on track to move to a new stage in the second quarter.
The drug candidate, RDEA806, showed positive results in a Phase 2a study comparing the drug candidate with placebo, according to preliminary results. The company said it plans on moving the drug candidate into a Phase 2b clinical trial during the second quarter. That study would also focus on safety and effectiveness and would compare the experimental drug with Bristol-Myers Squibb Co.'s Sustiva.
Shares of Ardea Biosciences rose 9 cents to close at $12.99.
30-Jan-08
Cowen & Co Initiated
coverage on RDEA
with an Outperform
Insider and fund buying over the past month in RDEA:
http://www.form4oracle.com/company?cik=0001103390&ticker=RDEA
Ardea Biosciences' Lead NNRTI for HIV, RDEA806, to Enter Phase 2a Proof-of- Concept Clinical Trial
Monday December 31, 8:30 am ET
CARLSBAD, Calif., Dec. 31 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has authorized a Phase 2a clinical trial evaluating RDEA806, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), in patients with human immunodeficiency virus (HIV), the causative agent of AIDS.
http://biz.yahoo.com/prnews/071231/aqm005.html?.v=33
Ardea Biosciences, Inc. Announces New Clinical Development Program Directed Toward the Treatment of Gout
Wednesday November 28, 8:00 am ET
- RDEA806 Shown to Produce Statistically Significant, Dose-Dependent Reduction in Serum Uric Acid in Phase 1 Clinical Study
- Phase 2 Efficacy Study in Gout Patients to Start in the First Half of 2008
CARLSBAD, Calif., Nov. 28 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News) today announced the initiation of a new clinical development program directed toward the treatment of gout. Gout, also known as metabolic arthritis, is a painful and debilitating disease caused by abnormally elevated levels of uric acid in the blood stream. These abnormally elevated levels lead to the deposition of uric acid crystals in and around the connective tissue of the joints and in the kidneys, leading to inflammation, the formation of disfiguring nodules (tophi), intermittent attacks of severe pain (acute flares), and kidney damage (nephropathy). An estimated 3-5 million people in the U.S. suffer from gout, which is the most common form of inflammatory arthritis in men over 40.
"We are extremely excited to be launching this new development initiative," said Barry D. Quart, Pharm.D., President and Chief Executive Officer. "Gout represents a major medical challenge in the U.S. and throughout the world, and, with no new treatments approved by the U.S. Food and Drug Administration for the underlying cause of gout in the past 40 years, there is a significant need for new therapeutic agents."
Phase 1 Experience
Earlier this year, Ardea conducted a comprehensive Phase 1 program in 98 healthy volunteers to evaluate the safety and pharmacokinetics of RDEA806, its lead non-nucleoside reverse transcriptase inhibitor (NNRTI) for the potential treatment of HIV. The Phase 1 program included a double-blind, placebo-controlled, multiple-ascending-dose (MAD) study in which 24 healthy volunteers received one of three doses of RDEA806 or placebo for 10-14 days. As reported earlier (http://www.ardeabio.com/publications_posters.html), RDEA806 was safe and well-tolerated at all doses evaluated with no serious adverse events or clinically significant laboratory or ECG abnormalities. Furthermore, a trend toward a reduction in plasma cholesterol and triglyceride levels was reported.
Further analysis of the data from the MAD study showed a statistically significant, exposure-dependent reduction in serum uric acid (SUA). In the dose group that resulted in the highest plasma drug levels (400 mg modified-release capsule twice daily), there was a 50.9% placebo-adjusted reduction in SUA (p < 0.001). The following table summarizes the results by dose group.
Effect of RDEA806 on Serum Uric Acid (SUA) Levels in Phase 1 MAD Study
Mean SUA Level (mg/dL)
Baseline Day 3 Day 10/14[1] Change P Value[2]
Placebo 5.66 6.12 5.78 +3.0 %
300 mg BID [3] 6.19 4.50 4.15 -31.6 % < 0.001
500 mg BID [3] 4.94 2.94 3.06 -38.1 % < 0.001
400 mg MR BID [3][4] 5.25 2.99 2.80 -47.9 % < 0.001
[1] Patients receiving 300 mg and 500 mg BID were dosed for
14 days; patients receiving 400 mg MR BID were dosed for 10 days.
[2] ANCOVA model for the change from baseline versus placebo.
[3] BID = twice daily.
[4] MR= modified-release capsules. This dose group achieved the
highest plasma drug levels.
The magnitude of the uric acid reduction correlates with the individual's baseline uric acid level, such that the higher the baseline uric acid level, the larger the absolute uric acid reduction. On the last day of dosing, this correlation is highly statistically significant (p=0.004). To this end, the volunteers who met the accepted definition of hyperuricemia at baseline (SUA greater than 6.8 mg/dL, the limit of uric acid solubility in serum) experienced the greatest decrease, an average of 3.2 mg/dL on the last day of dosing.
Development Plan
Ardea is preparing to initiate a Phase 2, dose-ranging clinical efficacy study in gout patients with hyperuricemia in the first half of 2008. The Company is currently investigating the active moiety responsible for this pharmacological effect and its mechanism of action, as these may influence further development plans.
Current Treatment Options
Despite the well-understood etiology of gout, current treatment options are limited. There have been no new therapies approved by the FDA for the treatment of hyperuricemia associated with gout in the past 40 years, and the most-prescribed, FDA-approved pharmaceutical agent, allopurinol, has significant limitations. According to a large, randomized, clinical study, only 21% of patients receiving allopurinol achieve their treatment target, while 8% experienced serious adverse events (1).
http://biz.yahoo.com/prnews/071128/aqw013.html?.v=37
Ardea Biosciences, Inc. Reports Third Quarter 2007 Operating and Financial Results
Wednesday November 14, 4:45 pm ET
Recent Accomplishments Include:
- Successful completion of Phase 1 studies of novel HIV NNRTI, RDEA806
- Presentation of Phase 1 data on RDEA806 at key infectious disease conference
- Clearance granted by FDA to commence Phase 1 clinical trials in advanced cancer patients with lead MEK inhibitor, RDEA119
- Presentation of RDEA119 preclinical data at key oncology conference
CARLSBAD, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. ("Ardea" or the "Company") (Nasdaq: RDEA - News), a company focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases, today reported financial and operating results for the three months and nine months ended September 30, 2007.
Ardea reported a loss applicable to common stockholders of $7.4 million ($0.72 per basic and diluted share) on revenues of $1.1 million for the third quarter of 2007, compared to a profit of $116,000 ($0.01 per share) for the third quarter of 2006. For the nine months ended September 30, 2007, the Company lost $16.2 million ($1.67 per basic and diluted share) on revenues of $2.8 million, compared to a loss of $131,000 ($0.01 per share) for the corresponding nine-month period in 2006. During 2006, the Company had no revenue. The results for the quarter and nine months ended September 30, 2007 include respective non-cash charges of $421,000 ($0.04 per share) and $784,000 ($0.08 per share) for stock compensation expense. The difference between 2007 and 2006 results reflects Ardea's re-start and rebuilding of operations.
"This past quarter proved to be highly productive," said Barry D. Quart, President and CEO. "We made significant progress in advancing our business and in the development of our pipeline, achieving several important milestones." These include:
-- Completion of Phase 1 single-ascending-dose, multiple-ascending-dose,
food-effect, and drug-interaction clinical studies of RDEA806, our lead
non-nucleoside reverse transcriptase inhibitor (NNRTI) for HIV, in
August of 2007;
-- Presentation of four posters describing the favorable results of
preclinical and Phase 1 clinical trials with RDEA806 during the 47th
Annual Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC);
-- Completion, submission and FDA approval of our investigational new drug
application (IND) for our lead mitogen-activated ERK kinase (MEK)
inhibitor, RDEA119, allowing us to proceed to Phase 1 clinical trials
in advanced cancer patients; and
-- Presentation of RDEA119 preclinical data, showing favorable properties,
including oral dosing, excellent selectivity and low central nervous
system (CNS) penetration, at the American Association of Cancer
Research (AACR), National Cancer Institute (NCI) and European
Organization for Research and Treatment of Cancer (EORTC) International
Conference on Molecular Targets and Cancer Therapeutics.
http://biz.yahoo.com/prnews/071114/aqw052.html?.v=34
New Oral MEK Inhibitor, RDEA119, Shows Favorable Anti-Tumor Properties
Wednesday October 24, 2:40 pm ET
- Ardea Biosciences, Inc. Presents Initial Data on RDEA119 at the 2007 AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics -
SAN FRANCISCO, Oct. 24 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA - News), a company focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases, today presented preclinical data on its lead MEK inhibitor, RDEA119, at the American Association of Cancer Research (AACR), National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) International Conference on Molecular Targets and Cancer Therapeutics in San Francisco.
Defects in the RAS/RAF/MEK/ERK signaling pathway are closely associated with the development of human tumors, such as melanoma, colon, lung and thyroid cancers. RDEA119, the lead compound from Ardea's MEK Inhibitor Program, is a potent, non-ATP competitive, highly-selective inhibitor of mitogen-activated ERK kinase (MEK).
"Our preclinical data suggest that RDEA119 has favorable properties, including oral dosing, excellent selectivity and low central nervous system (CNS) penetration," said Barry D. Quart, PharmD, President and CEO. "In mouse xenograft studies, when RDEA119 was dosed orally once daily for 14 days, we saw significant inhibition and delay of tumor growth. We observed inhibition of pERK in tumors (the target of therapy) at significantly lower concentrations (EC50 = 73 nM), compared to those required to inhibit brain pERK (EC50 > 5,000 nM). This very limited brain penetration suggests the potential for reduced CNS side effects. We currently plan to initiate a Phase 1 study of RDEA119 in patients with advanced cancer this quarter and plan to evaluate RDEA119 for inflammatory diseases next year."
About RDEA119 and Ardea's MEK Inhibitor Program
Ardea Biosciences has a broad-based R&D program focused on the design and development of small-molecule inhibitors of mitogen-activated ERK kinase, or MEK, for the treatment of cancer and inflammatory diseases. Since defects in the RAS/RAF/MEK/ERK signaling pathway are closely associated with the development of human tumors, such as melanoma, colon, lung and thyroid cancers, inhibiting MEK signaling has promise in the treatment of many types of cancer. MEK inhibitors may also play an important role in the potential treatment of inflammatory diseases, such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD) and psoriasis, due to their ability to down-regulate inflammatory cytokines, such as TNF alpha.
RDEA119, Ardea's lead compound from this program, is a potent, non-ATP competitive, highly- selective inhibitor of MEK. Ardea plans to initiate a Phase 1 clinical trial evaluating RDEA119 in advanced cancer patients in the fourth quarter of 2007. Preclinical data suggest that RDEA119 may have favorable pharmaceutical properties, including the potential for convenient oral dosing and limited retention in the brain, which, in turn, may result in a reduced risk of CNS side effects. Beyond RDEA119, the Company is evaluating a broad range of MEK inhibitors from several distinct chemical classes and plans to bring forward one of these compounds into a first-in-human study in the fourth quarter of this year.
About Ardea Biosciences, Inc.
Ardea Biosciences is focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases. The Company plans to initiate clinical studies on four compounds this year. These include RDEA806, the Company's lead non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV, which recently completed Phase 1 clinical trials, RDEA119, a mitogen-activated ERK kinase (MEK) inhibitor for the treatment of cancer and inflammatory diseases, which has been cleared by the FDA to enter Phase 1 clinical trials, and a follow-on NNRTI and a follow-on MEK inhibitor, both of which are scheduled to enter first-in-human studies in the fourth quarter of 2007.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Ardea's goals, including its goal of initiating a Phase 1 study of RDEA119 in patients with advanced cancer in the fourth quarter of 2007, evaluating RDEA119 for inflammatory diseases next year, and initiating clinical studies on three additional compounds this year, the expected properties and benefits of its compounds and the results of clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcomes of preclinical and clinical trials, risks related to regulatory approvals, delays in commencement of preclinical and clinical tests, and costs associated with internal development and in-licensing activities. These and other risks and uncertainties are described more fully in Ardea's most recently filed SEC documents, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, under the headings "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Ardea undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Source: Ardea Biosciences, Inc.
Ardea Biosciences to List on the NASDAQ Capital Market
- Ardea Common Stock to Trade Under the Symbol RDEA -
CARLSBAD, Calif., Oct. 9 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA), a company focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases, today announced that the NASDAQ Listing Qualifications Department of The NASDAQ Stock Market LLC has approved the Company's application for listing of its common stock on The NASDAQ Capital Market. Ardea anticipates that its common stock will begin trading on The NASDAQ Capital Market at the market opening on Wednesday, October 10, 2007 under the symbol 'RDEA.'
About Ardea Biosciences, Inc.
Ardea Biosciences is focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases. The Company plans to initiate clinical studies on four compounds this year. These include RDEA806, the Company's lead non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV, which recently completed Phase 1 clinical trials, RDEA119, a mitogen-activated ERK kinase (MEK) inhibitor for the treatment of cancer and inflammatory diseases, which has been cleared by the FDA to enter Phase 1 clinical trials, and a follow-on NNRTI and a follow-on MEK inhibitor, both of which are scheduled to enter first-in-human studies in the fourth quarter of 2007.
Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Ardea's goals, including its goal of initiating a Phase 1 study of RDEA119 and initiating clinical studies on three additional compounds this year, the expected properties and benefits of its compounds and the results of clinical and other studies. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the outcomes of preclinical and clinical trials, risks related to regulatory approvals, delays in commencement of preclinical and clinical tests, and costs associated with internal development and in-licensing activities. These and other risks and uncertainties are described more fully in Ardea's most recently filed SEC documents, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, under the headings 'Risk Factors.' All forward-looking statements contained in this press release speak only as of the date on which they were made. Ardea undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
SOURCE Ardea Biosciences, Inc.
Source: PR Newswire (October 9, 2007 - 8:15 AM EDT)
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