Vertex's hepatitis C drug VX-950 receives FDA fast track designation

By Angela McDaniels

Seattle, Dec. 8 - Vertex Pharmaceuticals Inc. said the U.S. Food and Drug Administration has granted fast track designation to VX-950, an investigational oral hepatitis C virus protease inhibitor.

Fast track designation indicates that the FDA will assist the development and may expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.

Vertex said VX-950 has the potential to shorten the duration of therapy compared to the standard of care, which may result in improved sustained virologic response rates and a more favorable adverse event profile.

Earlier in 2005, Vertex concluded a 14-day, phase 1b study of VX-950 that showed a rapid and dramatic reduction in hepatitis C viral RNA in patients when VX-950 was administered as a single agent.

Adverse events observed in patients receiving VX-950 were mild and generally similar in frequency to events in the placebo group, the company said.

Based on these results, Vertex recently began two additional clinical studies with VX-950: in Europe, a 20-patient phase 1b study of VX-950 dosed in combination with pegylated interferon and in the United States, the first phase 2 study of VX-950, which will evaluate the safety, tolerability and pharmacodynamics of VX-950 when dosed with pegylated interferon and ribavirin.

Vertex expects to obtain results from these in early 2006 and to initiate multiple additional phase 2 studies in the United States in 2006, including a three-month study in more than 200 treatment-naive patients.

Hepatitis C, a liver disease caused by the hepatitis C virus, affects 3.4 million individuals in the United States and is spread through direct contact with the blood of infected people, the company said. Hepatitis C significantly increases a person's risk for developing long-term infection, chronic liver disease, cirrhosis or death.

Vertex Pharmaceuticals is a biotechnology company based in Cambridge, Mass., that develops small molecule drugs for the treatment of serious diseases such as viral diseases, inflammation, autoimmune diseases and cancer.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.