Vertex files application with FDA for phase II studies of VX-950 for hepatitis C treatment

By E. Janene Geiss

Philadelphia, Nov. 11 - Vertex Pharmaceuticals Inc. said that data from a 14-day study of VX-950 showed the investigation's oral hepatitis C protease inhibitor was well-tolerated and possessed potent antiviral activity in patients with hepatitis C virus infection.

The company also said Friday that it filed an investigational new drug application with the U.S. Food and Drug Administration to support phase II clinical development of VX-950, according to a company news release.

The study's findings of rapid decline in plasma HCV-RNA levels and viral kinetic analysis that projects the potential duration of treatment required to achieve sustained virologic response support the evaluation of VX-950 in a novel, three-month combination treatment paradigm, officials said.

"The clinical data demonstrate a swift and dramatic decline in viral levels with VX-950, and provide insight into VX-950's potential to transform future HCV treatment," Joshua Boger, chairman, president and chief executive officer of Vertex, said in the release.

The company presented data of the 14-day study this week at the annual American Association for the Study of Liver Diseases.

San Francisco-based Vertex is a biotechnology company focused on discovery and development of breakthrough small molecule drugs for serious diseases.

© 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.