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Vertex to Partner with Janssen, GSK on Hepatitis C Drugs

Microscopic view of the hepatitis C virus (VA.gov)

Microscopic view of the hepatitis C virus (VA.gov)

Vertex Pharmaceuticals Inc. in Cambridge, Massachusetts will collaborate with Janssen Pharmaceuticals, a division of Johnson & Johnson, and GlaxoSmithKline (GSK) on clinical trials of Vertex’s VX-135 treatment candidate for hepatitis C. The trials will test VX-135 in combination with hepatitis C drugs made by Janssen and GSK. Financial details of the agreements were not disclosed.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people with hepatitis C have no symptoms of the disease until liver damage occurs, which may take several years. The Centers for Disease Control and Prevention estimates between 2.7 and 3.9 Americans are living with hepatitis C, which causes some 12,000 deaths per year.

VX-135 targets the proteins needed to replicate the hepatitis C virus, to inhibit that replication process. Vertex says that in preclinical studies, VX-135 exhibited anti-viral capability against all forms of the hepatitis C virus, including those found outside the U.S. Vertex licensed the VX-135 technology from Alios BioPharma in June 2011.

Vertex will test VX-135 with Janssen’s protease inhibitor simeprevir, being developed with Medivir AB to treat chronic hepatitis C virus infections. Vertex and Janssen will first conduct an interaction study between the two drugs, followed by a proof-of-concept phase 2 clinical trial to evaluate safety, tolerability, and viral cure rates using a 12-week combination of VX-135 and simeprevir.

GSK will test its related protease inhibitor GSK2336805 with VX-135. As with the Janssen research, this study will be a phase 2 proof-of-concept clinical trial to evaluate safety, tolerability, and viral cure rates of the two drugs in combination for 12 weeks. Both trials will begin in early 2013, and enroll people who have chronic non-cirrhotic hepatitis C and have not previously been treated.

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