News + Font Resize -

IND application for ViroPharma's HCV-796 submitted with US FDA
Exton, Pennsylvania | Friday, January 7, 2005, 08:00 Hrs  [IST]

ViroPharma Incorporated has announced that its partner in the development of antiviral compounds targeting hepatitis C (HCV), Wyeth Pharmaceuticals, a division of Wyeth has submitted an investigational new drug (IND) application to the US FDA to evaluate ViroPharma's compound HCV-796, a novel polymerase inhibitor, as a potential new product to treat hepatitis C.

Under this IND, a protocol has been prepared to assess the safety and tolerability of HCV-796 in healthy adult volunteers, as well as to gather pharmacokinetic data. Preclinical studies have shown HCV-796 may be more potent than other anti-HCV compounds developed to date between the two companies.

"The filing of this IND represents an additional step in our goal to identify new drugs to combat hepatitis C and we are excited to kick off the development of this promising molecule," said Dr. Colin Broom, ViroPharma's chief scientific officer.

"We now have two anti-HCV compounds in development. We expect to begin dosing patients in the HCV-796 trial later this quarter, and hope to initiate proof of concept studies with the compound during the second quarter of 2005. In addition, our proof of concept trial with HCV-086 is moving forward expeditiously, and we continue to expect to have the data from the trial available later this quarter. It is our hope that we may one day offer patients suffering from hepatitis C an efficacious and well-tolerated option to the currently available therapies," he added.

ViroPharma and Wyeth are engaged in a collaboration to develop and commercialize antiviral compounds to treat HCV.

Post Your Comment

 

Enquiry Form