They are also testing 806 (phase IIa) in gout syndrome because it showed reduction of uric acid in healthy people but I can't figure out the mechanism.
In the CC yesterday, Ardea said that in the phase IIa, plasma lipid levels (particularly triglycerides) stabilized or decreased over the course of treatment with RDEA806. A similar trend was observed in the phase I studies. I'm not sure if Intelence has a similar effect on lipid profile (I think that Sustiva has the opposite trend). And how do other NNRTIs (IDX899) behave? T.i.a
SAN DIEGO, March 24 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA ), 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.
About Ardea Biosciences
Ardea Biosciences, 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 three 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 are also investigating RDEA806 for the treatment of gout. Our lead mitogen-activated ERK kinase (MEK) inhibitor, RDEA119, is in a Phase 1 study in advanced cancer patients and is being investigated for the treatment of inflammatory diseases. RDEA436, our second generation MEK inhibitor for the treatment of cancer and inflammatory diseases, has been evaluated in a human micro-dose pharmacokinetic study and has been selected as a development candidate. In addition to the foregoing clinical programs, we are developing a second generation NNRTI for HIV, as well as other drug candidates in earlier stages of preclinical development and discovery. <<
RDEA Reports Additional Monotherapy Data for RDEA806 in HIV
[RDEA reported data from the first two dosing cohorts of this phase-2a trial (400mg BID and 600mg qD, both using a capsule formulation) in March (#msg-27712847). The two new dosing cohorts reported today are 800mg qD and 1000mg qD, both using an enteric tablet. The doses to be carried forward into combination-therapy testing in phase-2b are 600mg, 800mg, and 1000mg qD using the tablet formulation. RDEA806 is a direct competitor of IDIX’s IDX899 (and various other compounds) in the contest to supersede Sustiva as the NNRTI of choice in a three-drug cocktail including GILD’s Truvada.]
>> 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
SAN DIEGO, June 25 /PRNewswire-FirstCall/ -- Ardea Biosciences, Inc. (Nasdaq: RDEA ) 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. <<
News 
Market Data 
Discover 
AI
