Yahoo! - Vertex begins phase Ib hepatitis C trial Messenger
- Tuesday November 9, 04:50 PM
Vertex begins phase Ib hepatitis C trial
Global biotech firm Vertex Pharmaceuticals (NASDAQ: VRTX - news) , a small-molecule drugs developer, has initiated a phase Ib clinical trial for its investigational oral protease inhibitor for the treatment of hepatitis C infection.
Global biotech firm Vertex Pharmaceuticals, a small-molecule drugs developer, has initiated a phase Ib clinical trial for its investigational oral protease inhibitor for the treatment of hepatitis C infection.
The double-blind, placebo-controlled study will evaluate the tolerability, pharmacokinetics and viral kinetics of multiple, ascending doses of VX-950 over a period of up to 14 days and will enroll approximately 60 subjects. This is the first reported initiation of a study that involves 14 days of administration of a hepatitis C virus (HCV) protease inhibitor in patients with chronic hepatitis C infection.
The clinical study will first assess healthy volunteers receiving multiple doses of VX-950 for a five-day period. Following this initial assessment, the study will evaluate three different doses of VX-950 in HCV patients, over 14 days of treatment in serially configured dose groups.
Pre-clinical studies have shown that VX-950 significantly reduces levels of HCV RNA in both an in vitro replicon system and infectious virus assays. In the phase Ia clinical study, VX-950 was well-tolerated and demonstrated oral bioavailability.
Furthermore, combined clinical and pre-clinical pharmacokinetic results indicate that VX-950 can be administered in a dose regimen that may achieve liver concentrations substantially greater than target concentrations (IC50 and IC90 in non-clinical studies).
"The phase Ib study is expected to provide us with important information on the ability of VX-950 to reduce viral load, which we expect will help to define the potential clinical impact of this new class of drugs," said Dr John Alam, senior vice president of drug evaluation and approval at Vertex.
Vertex anticipates that the phase Ib study will be completed in the first half of 2005.
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