Idenix Pharmaceuticals Highlights Progress in Three HCV Programs
11 January 2010 - 10:45PM
PR Newswire (US)
- Interim analysis of 50 mg cohort demonstrates potent HCV
antiviral activity at 14 days for IDX184, a nucleotide polymerase
inhibitor, in combination with PegIFN/Ribavirin - IDX375, a
non-nucleoside polymerase inhibitor, exhibited favorable
pharmacokinetic properties in a Phase I healthy volunteer study -
Clinical Trial Application filed in December 2009 for IDX320, a
next-generation protease inhibitor CAMBRIDGE, Mass., Jan. 11
/PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc.
(NASDAQ:IDIX), a biopharmaceutical company engaged in the discovery
and development of drugs for the treatment of human viral diseases,
today announced significant progress in three HCV programs. Idenix
will provide a business update on these three HCV development
programs and on its partnered programs during a presentation by
Jean-Pierre Sommadossi, Ph.D., chairman and chief executive
officer, to financial analysts and investors at the 28th Annual
J.P. Morgan Healthcare Conference in San Francisco on Thursday,
January 14 at 8:00 a.m. PST. IDX184: Nucleotide HCV Polymerase
Inhibitor The phase II clinical trial, initiated in the fourth
quarter of 2009, is a randomized, double-blind, placebo-controlled,
sequential dose-escalation study evaluating the safety,
tolerability, pharmacokinetics and antiviral activity of IDX184 in
combination with pegylated interferon and ribavirin in
treatment-naive HCV genotype 1-infected patients. Patients will
receive a daily dose of IDX184 or placebo plus pegylated interferon
and ribavirin for 14 days and then continue on pegylated interferon
and ribavirin for an additional 14 days. Antiviral activity will be
assessed at the 14-day and 28-day timepoints. Four dosing regimens
of IDX184 ranging from 50 to 200 mg per day will be evaluated. In
the 100 mg and 200 mg cohorts, QD and BID regimens will be
compared. Each cohort includes 20 patients randomized 4:1,
IDX184:placebo. This study is being conducted at multiple centers
in the United States and Argentina. Interim analysis of the first
10 patients randomized into the first cohort (50 mg QD): Patients
with Undetectable Median Change in HCV RNA Viral Load at Day 14
Cohort (log10) at Day 14 (