SAN DIEGO, June 2 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) announced today the initiation of dosing in a Phase I clinical trial of ANA598, an investigational oral non-nucleoside polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The objectives of this trial are to assess safety, tolerability, and pharmacokinetics following ascending single oral doses of ANA598 in healthy volunteers. Approximately 40 healthy subjects will participate in the study, which is being conducted in the United States. Following successful completion of the healthy volunteer study, Anadys plans to begin a Phase Ib study of ANA598 in HCV-infected patients in the third quarter of 2008.
"Based on its very favorable preclinical profile, including potency, pharmacokinetics, and tolerability, we believe ANA598 has the potential to become an important component of future combination therapy for patients with HCV infection," said James Freddo, M.D., Anadys' Chief Medical Officer. "We are excited about initiating this clinical program and look forward to future trials of ANA598 in HCV patients, first as a single agent and then in subsequent combination studies. We expect the full benefit of direct antivirals to be demonstrated when studied as components of novel combination regimens incorporating multiple anti-HCV agents."
Steve Worland, Ph.D., Anadys' President and CEO commented, "This is a significant milestone for Anadys. ANA598 is the second internally discovered compound that we've moved into clinical studies this year. With the commencement of dosing in a Phase I clinical trial for ANA773 in cancer patients in February and this study of ANA598 underway, Anadys is now focused on achieving important clinical milestones in both programs."
About ANA598
ANA598 is a highly potent and selective inhibitor of HCV genotypes 1a and 1b NS5b RNA polymerases (IC50<1 nM) and of HCV replication in cell culture (EC50 values for genotypes 1b and 1a replicons are 3 and 50 nM, respectively). ANA598 has been well-tolerated in all preclinical studies, including 28-day GLP toxicology studies, and was selected as a development candidate in June 2007. <<
Anadys Resumes Clinical Investigation of TLR7 Mechanism in HCV
[The word “resumes” applies insofar as ANDS had to terminate its first-generation TLR7 drug for HCV, ANA975, due to toxicity (#msg-21600252). The new TLR7 drug, ANA773, will begin a two-part phase-1 trial in both healthy volunteers and patients. ANDS is also working on an HCV non-nucleoside polymerase inhibitor called ANA598, which is in phase-1 (#msg-29733427).]
Expanded HCV Development Presence Includes ANA598 and ANA773 Acting via Independent but Potentially Complementary Mechanisms
Conference Call Today at 2:00 PM PDT
SAN DIEGO, July 7 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS ) announced today that it is resuming clinical investigation of the Toll-Like Receptor-7 (TLR7) mechanism for the treatment of chronic hepatitis C. Based on preclinical pharmacology testing and the results of completed 13-week GLP animal toxicology studies, Anadys has received clearance to initiate a clinical trial of ANA773, the Company's oral TLR7 agonist prodrug, under a clinical trial application (CTA) in the Netherlands. Following initial dosing in healthy volunteers, this trial will explore every-other-day dosing over 28 days in HCV patients. Anadys also continues to enroll patients in a separate Phase I clinical trial of ANA773 in oncology that is ongoing under an IND in the United States.
"In an extensive preclinical program conducted with ANA773, we have previously shown that the profile of immune stimulation resulting from TLR7 activation can be dramatically modulated by altering the schedule of administration," said James Freddo, M.D., Anadys' Chief Medical Officer. "Now, results of toxicology studies employing every-other-day dosing of ANA773 have shown that we can achieve desired levels of immune stimulation sustained over 13 weeks without adverse toxicology findings. The favorable toxicology profile seen to date, coupled with the stable induction of interferon-alpha dependent responses when ANA773 is dosed every other day over 13 weeks, have convinced us that ANA773 has the potential to demonstrate benefit in patients infected with HCV."
Steve Worland, Ph.D., Anadys' President and CEO, commented, "The decision to take ANA773 into HCV, which will be our third clinical development program to commence dosing this year, reflects an expansion of Anadys' development efforts in HCV. As an approach to treat hepatitis C, the TLR7 mechanism is independent from, and potentially complementary to, ANA598, Anadys' non-nucleoside HCV polymerase inhibitor currently in Phase I clinical development." Commenting on the expected impact this expansion will have on the Company's cash outlook for 2008, Dr. Worland added, "Because the ANA773 hepatitis C program is highly leveraged off our oncology program, we expect to carry forward all three clinical development programs this year within our previous 2008 cash utilization projection of $29 to $31 million."
ANA773 Phase I Clinical Trial in HCV
The Phase I clinical trial of ANA773 in HCV will be conducted under a two-part protocol. Part A of the study will include both single and multiple doses of ANA773 in healthy volunteers. Successive cohorts of volunteers will receive ascending dose levels of ANA773. The primary objectives of Part A of the study are to assess safety and tolerability. In Part B of the study, HCV patients will receive ANA773 every other day for 28 days. The primary objectives of Part B are to assess safety, tolerability and viral load decline. The starting dose level in HCV patients will be selected based on safety, tolerability and immune responses seen in healthy volunteers in Part A. It is expected that this study design will allow initial dosing in HCV patients at a dose that will have demonstrated a desired magnitude of immune stimulation in the healthy subjects, and that dosing in patients will initiate prior to completion of dose escalation in Part A of the study. Approximately 40 healthy volunteers and 24 patients are anticipated to be enrolled in this study. Dosing is expected to begin in healthy volunteers within the next few weeks and in HCV patients early in the fourth quarter of 2008.
About ANA773 and TLR Pharmacology
ANA773 is an orally administered prodrug of a novel TLR7-specific agonist. Results from pre-clinical pharmacology studies have shown that ANA773 can elicit desired immune responses and that the profile of response can be modulated by both dose and schedule of administration. Results of recently completed 13-week GLP toxicology studies have shown that with every-other-day dosing of ANA773, immune stimulation of a magnitude believed to confer therapeutic potential can be achieved without adverse toxicology findings. The immune stimulation observed with every-other-day dosing of ANA773 in monkeys included induction of interferon-alpha and interferon dependent responses at levels that are sustained over 13 weeks of dosing.
The recently obtained results with every-other-day dosing of ANA773 over 13 weeks contrast with results from prior 13-week animal toxicology studies that utilized daily dosing of ANA975, a TLR7 agonist prodrug previously in development by the Company for the treatment of chronic hepatitis C. In initial 13-week animal toxicology studies of ANA975 dosed daily, unexpected findings associated with intense immune stimulation were observed. When lower daily doses of ANA975 were then explored in a subsequent 13-week animal toxicology study, it was determined that adverse findings were present even at dose levels where desired immunostimulatory effects were not measurable, following which the decision was made in 2007 to discontinue development of ANA975.
Webcast of Conference Call
Anadys will host a conference call today, July 7, 2008 at 2:00 p.m. Pacific Daylight Time to discuss Anadys' plans to resume clinical investigation of the TLR7 mechanism in HCV. A live webcast of the call will be available online at http://www.anadyspharma.com. A telephone replay will also be available approximately one hour after completion of the call. To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 84526379. The webcast and telephone replay will be available through July 21, 2008.
About Anadys
Anadys Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company dedicated to improving patient care by developing novel medicines in the areas of hepatitis C and oncology. For the treatment of chronic hepatitis C, the Company is developing ANA598, a non-nucleoside polymerase inhibitor, and ANA773, an oral TLR7 agonist prodrug. The Company is also developing ANA773 for the treatment of cancer.‹
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