Positive interim (12 week) Phase IIb data for Anadys's non nuc Setrobuvir + p/r in both treatment naive and non-responders to previous P/R. Looks to be comparable to P/R in side effect profile, except for the amount of rash (39%) (98% mild to moderate)
Anadys Announces Positive 12-Week Data for Setrobuvir in Phase 2b Hepatitis C Study
- Strong Antiviral Response in Prior Partial Responders and Relapsers - Favorable Safety Data with AE Profile Comparable to Control Group - High Barrier to Resistance Confirmed --Conference Call at 8:00 AM EDT Today
SAN DIEGO, Oct. 13, 2011 Anadys Pharmaceuticals today released interim antiviral response and safety data from an ongoing Phase IIb study of setrobuvir in combination with pegylated interferon and ribavirin (P/R) in genotype 1 hepatitis C patients. Setrobuvir is the Company's direct-acting antiviral being developed for the treatment of chronic hepatitis C, or HCV.
"We are pleased with today's data, which we believe demonstrate a compelling profile for setrobuvir in significantly more patients," said Steve Worland, Ph.D., President and CEO of Anadys. "The antiviral response in patients who had failed prior treatment is a particularly encouraging benchmark of setrobuvir's potency and high barrier to resistance. Coupled with a favorable safety profile to date, we believe today's data position setrobuvir as a very attractive agent to be included in future DAA combination regimens."
78% of treatment-naive patients and 76% of patients who had responded inadequately to, or relapsed after, prior treatment with P/R had undetectable virus at week 12 (cEVR) while receiving setrobuvir plus P/R, compared to 56% and 44%, respectively, for patients who received placebo plus P/R. 71% of treatment-naive patients who received setrobuvir plus P/R had undetectable virus at week 8 and met the initial response-guided criteria for shortening treatment in this study to 28 weeks from the traditional 48 weeks for treatment with P/R alone.
29% of patients who had no appreciable response to prior treatment with P/R (null responders) achieved cEVR with setrobuvir plus P/R, and the percentage of patients with undetectable virus continued to climb in this hard-to-treat population to 36% at week 18. No prior null responders received placebo plus P/R in this trial.
The viral breakthrough rate through 12 weeks on setrobuvir plus P/R was low in both treatment-naïve patients (2.9%) and patients who had responded inadequately to, or relapsed after, prior treatment with P/R (3.6%). The Company believes this low incidence of viral breakthrough exhibited to date in a larger patient population further characterizes setrobuvir's high barrier to resistance.
Setrobuvir has been generally well-tolerated in the study. Safety data for patients receiving setrobuvir plus P/R, and comparison to the control group that received placebo plus P/R, are being reported through a time period that reflects a median dosing duration of 19 weeks. The rate of discontinuing treatment in the study due to adverse events has been similar in patients receiving setrobuvir plus P/R (5.6%) or P/R alone (5.9%). The profile of adverse events has been similar between the setrobuvir and control groups, with reported adverse events being typical for patients treated with interferon and ribavirin. In the setrobuvir group, 39% of patients (84/215) developed a rash while 22% (15/68) of patients in the control group developed a rash. 98% of the rashes in the setrobuvir group were mild or moderate (grade 1 or grade 2), compared to 93% in the control group. There were no Grade 4 rashes in either group. The incidence of rash in the setrobuvir group is consistent with prior reports of rash due to interferon and ribavirin through 19 weeks of treatment.
Proportion of patients with undetectable virus at Week 12 (cEVR)
setrobuvir + P/R placebo + P/R
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Treatment-naive patients 78% 56%
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Treatment-experienced patients
prior partial responder or relapser 76% 44%
prior null responder 29% ---
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Phase 2b Protocol Design
283 patients were dosed in this study. Patients received either setrobuvir 200 mg twice a day (bid) in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin, USP) (P/R) with a loading dose of setrobuvir 800 mg bid on day 1, or placebo plus P/R. Patients who had a prior null response to P/R, defined as less than a 1 log10 decline in viral load at week 4 or less than a 2 log10 decline at week 12 during prior treatment, were not randomized to receive placebo. All other patients were stratified by IL28B genotype (CC/non-CC) between setrobuvir and placebo groups. The interim antiviral response data is being reported as the proportion of patients with undetectable virus (< 15 IU/mL) using the Roche COBAS HCV TaqMan assay. The primary endpoint of the study is Sustained Virological Response 24 weeks after patients conclude all treatment, known as SVR24. In addition to the interim data released today, data through 24 weeks of dosing are expected around year-end. The study is being conducted at sites in the United States, Canada, Australia and New Zealand.
Treatment-Naive Group
102 treatment-naive patients received setrobuvir plus P/R
36 treatment-naive patients received placebo plus P/R
Treatment-naive patients who achieved undetectable levels of virus by Week 8 and maintain undetectable levels of virus are scheduled to conclude all treatment at Week 28
For treatment-naive patients with detectable virus at Week 8, treatment with setrobuvir or placebo and P/R is scheduled to continue through Week 48
Treatment-Experienced Group (including prior null responders)
82 patients who were partial responders during, or relapsers after, a prior course of therapy with P/R alone received setrobuvir plus P/R
32 corresponding patients received placebo plus P/R
31 prior null responder patients received setrobuvir plus P/R
All treatment-experienced patients are scheduled to be treated for 48 weeks
About Setrobuvir
Setrobuvir is an HCV RNA polymerase inhibitor that belongs to a chemical class referred to as non-nucleosides. Setrobuvir has a well-characterized safety database in which more than 350 subjects have received the agent to date. Setrobuvir has received Fast Track Status from the FDA for the treatment of chronic hepatitis C. Earlier this year, Anadys announced a cross-company clinical trial agreement with a large, commercial-stage biopharmaceutical company to study setrobuvir in combination with another DAA in healthy volunteers.
Conference Call Webcast and Slides
Anadys will hold a conference call and webcast today, October 13, 2011 at 8:00 a.m. Eastern Daylight Time to discuss interim antiviral response and safety data from an ongoing Phase IIb study of setrobuvir in combination with P/R. A live webcast of the call, including accompanying slides, will be available online at www.anadyspharma.com . A telephone replay with slides 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 21814367. The webcast and telephone replay will be available through October 27, 2011.
Safe Harbor Statement
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such forward-looking statements include, but are not limited to, references to (i) the belief that the interim data described in this press release, coupled with a very favorable safety profile to date, position setrobuvir as a very attractive agent to be included in future DAA combination regimens, (ii) Anadys' belief that the low incidence of viral breakthrough exhibited to date further characterizes setrobuvir's high barrier to resistance, and (iii) setrobuvir's potency and adverse event profile based on the interim data reported in this press release. Such statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. For example, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that setrobuvir will not have unforeseen safety issues, will have favorable results in ongoing or future clinical trials or will receive regulatory approval. In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into transactions around its product candidates, its ability to successfully develop and market products, difficulties or delays in its non-clinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments and its ability to obtain additional funding to support its operations. Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-Q for the quarter ended June 30, 2011. All forward-looking statements are qualified in their entirety by this cautionary statement. Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche Inc.
SOURCE Anadys Pharmaceuticals, Inc.
Copyright (C) 2011 PR Newswire. All rights reserved
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