Date: 2012-11-01
Type of information: Initiation of the trial
phase: 2
Announcement: agreement for the initiation of a proof of concept study
Company: Vertex Pharmaceuticals (USA - MA) GSK (UK)
Product: VX-135 (ALS-2200) and GSK2336805
Action
mechanism: VX-135 (ALS-2200) is a uridine nucleotide analogue pro-drug that appears to have a high barrier to drug resistance based on in vitro studies. It is designed to inhibit the replication of the hepatitis C virus by acting on the NS5B polymerase. In vitro studies of the compound showed antiviral activity across all genotypes, or forms, of the hepatitis C virus, including genotypes more prevalent outside of the United States .
GSK2336805 is an investigational NS5A replication complex inhibitor being developed by GSK for the treatment of hepatitis C.
Disease: hepatitis C
Therapeutic area: Infectious diseases
Country: USA
Trial
details: The Phase 2 proof-of-concept study is expected to begin in early 2013, pending discussions with regulatory authorities, and will enroll people who have chronic non-cirrhotic genotype 1 hepatitis C and have not previously been treated (treatment-naïve). The study will be conducted in the U.S. by Vertex, and costs associated with the study will be split equally between the two companies. The goals of the study will be to evaluate safety, tolerability and viral cure rates (SVR12; undetectable hepatitis C virus 12 weeks after the end of treatment) of multiple 12-week combination regimens of VX-135 and GSK2336805, with and without ribavirin. Additional information on the Phase 2 study will be provided upon initiation of the study. Further clinical development activities beyond the Phase 2 proof-of-concept study are not covered as part of this agreement.
Latest
news: Vertex Pharmaceuticals has entered into a non-exclusive agreement with GSK to conduct a Phase 2 proof-of-concept study of an all-oral regimen for the treatment of hepatitis C containing Vertex\'s nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135 and GSK\'s NS5A inhibitor GSK2336805. Vertex and GSK plan to initiate the study in early 2013, pending discussions with regulatory authorities.
The study is expected to evaluate safety, tolerability and viral cure rates using a 12-week combination of VX-135 and GSK2336805. The companies will jointly fund costs associated with the study. There are no up-front or milestone payments associated with the agreement.
Earlier this year, Vertex announced the first 7-day viral kinetic data for VX-135. Based on these data, the company plans to initiate multiple all-oral, Phase 2 proof-of-concept studies, including a study of VX-135 and ribavirin and a study of VX-135 and telaprevir, the company\'s approved protease inhibitor marketed as INCIVEK for people with chronic genotype 1 hepatitis C. Vertex is on track to initiate the study of VX-135 in combination with ribavirin by the end of 2012, followed by the study with telaprevir in early 2013. The studies will evaluate safety, tolerability and viral cure rates (SVR12; undetectable hepatitis C virus 12 weeks after the end of treatment) of 12-week combination regimens in people with chronic non-cirrhotic genotype 1 hepatitis C who have not previously been treated (treatment-naïve).
