Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data on ALS-2200 (VX-135), an oral medicine Vertex is developing for the treatment of hepatitis C, are being presented for the first time at The Liver Meeting ®, the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). There was a median 4.54 log 10 reduction (range -3.81, -5.08) in hepatitis C virus (HCV) RNA after seven days of dosing with ALS-2200 (200 mg) once daily in people with genotype 1 chronic hepatitis C who were new to treatment (n=8). Similar reductions in HCV RNA were seen in a seven-day viral kinetic study of once daily ALS-2200 (200 mg) in combination with ribavirin (n=8). ALS-2200 was well-tolerated in this study, with no serious adverse events and no discontinuations due to adverse events. Based on these data, and to further characterize the medicine’s safety and efficacy profile, Vertex plans to begin multiple Phase 2 studies of 12-week all-oral regimens in people with genotype 1 hepatitis C in early 2013, pending discussions with regulatory authorities. These studies will include combinations of VX-135 with GSK2336805 and separately with simeprevir (TMC435). Upon the start of Phase 2 studies, ALS-2200 will be known as VX-135. Screening in the first study, which will evaluate VX-135 in combination with ribavirin, is expected to begin in the coming weeks.
“We’re working quickly to evaluate multiple all-oral treatment regimens with VX-135 and expect to have a significant amount of data from several Phase 2 studies by the end of 2013,” said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. “Our goal is to proceed to pivotal development with one or more regimens that have the greatest potential to offer doctors and the people they treat a more tolerable, short-duration therapy with high viral cure rates for hepatitis C.”