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VRUS/BMY Start All-Oral Phase-2a Trial of PSI-7977 + BMS-790052

[There are six arms in a 3x2 matrix: the 3-element axis of the matrix includes an arm of 24w combination treatment with ribavirin, an arm of 24w combination treatment without ribavirin, and an arm of 1-weak lead-in on PSI-7977 monotherapy followed by 23w of combination treatment without ribavirin; the 2-element axis of the matrix has arms for genotype -1 and for genotype-2/3. Patients in all six arms are treatment-naïve. (See the bulleted items below.)

The collaboration between VRUS and BMY to conduct this trial of a nuke + NS5A inhibitor was made in Jan 2011 (#msg-58596259). The trial description is at http://clinicaltrials.gov/ct2/show/NCT01359644 . The primary endpoint is SVR, which is expected to be reportable in Sep 2012.]

http://finance.yahoo.com/news/AllOral-Combination-Study-prnews-1258256197.html?x=0&.v=1

›Source: Pharmasset
Thursday May 26, 2011, 6:45 am EDT

PRINCETON, N.J., May 26, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq:VRUS) announced today the initiation of a Phase 2a trial investigating the combination of Pharmasset's PSI-7977, a nucleotide polymerase inhibitor, and BMS-790052, Bristol-Myers Squibb Company's (NYSE:BMY) NS5A replication complex inhibitor, for the treatment of chronic hepatitis C (HCV). This trial is the result of a clinical collaboration agreement between Pharmasset and Bristol-Myers Squibb announced in January 2011.

"We are happy to announce the initiation of this important combination trial," stated William Symonds, Pharmasset's Senior Vice President of Clinical Pharmacology and Translational Medicine. "Recent data from Bristol-Myers Squibb's combination study demonstrated that individuals with HCV can be cured without the traditional interferon and ribavirin, but only if two potent DAAs are used and drug resistance is avoided. We believe Pharmasset's nucleotide analogs have demonstrated potent antiviral activity and a high barrier to resistance and therefore have the potential to be the future backbone of interferon-free treatment."

About the Trial

This Phase 2a trial is planned to enroll approximately 84 patients with chronic HCV genotypes 1, 2 or 3 who have not been treated previously. The primary endpoint of the trial is sustained virologic response (SVR). The trial will be conducted in the U.S. Subjects will be randomized equally across each of the following arms:

• PSI-7977 400mg QD for 7 days, then add BMS-790052 60mg QD for further 23 weeks in genotype 1 subjects;

• PSI-7977 400mg QD for 7 days, then add BMS-790052 60mg QD for further 23 weeks in genotype 2 or 3 subjects;

• PSI-7977 400mg QD and BMS-790052 60mg QD for 24 weeks in genotype 1 subjects;

• PSI-7977 400mg QD and BMS-790052 60mg QD for 24 weeks in genotype 2 or 3 subjects;

• PSI-7977 400mg QD, BMS-790052 60mg QD and ribavirin for 24 weeks in genotype 1 subjects;

• PSI-7977 400mg QD, BMS-790052 60mg QD and ribavirin for 24 weeks in genotype 2 or 3 subjects.‹