BMS to present Phase III data for daclatasvir/asunaprevir combo

Next month, Bristol-Myers Squibb Co. (NYSE:BMY) will present data from the Phase III HALLMARK DUAL (AI447028) trial, which the company said formed the basis for the breakthrough designation for the combination of asunaprevir ( BMS-650032) and daclatasvir ( BMS-790052) to treat HCV genotype 1b infection. In the trial, once-daily oral daclatasvir plus twice-daily oral asunaprevir for 24 weeks led to a sustained virologic response (SVR) 12 weeks after the end of treatment in 90% of treatment-naïve patients (n=203), 82% of prior null or partial responders to peginterferon and ribavirin (n=205) and 82% of patients who were ineligible for or intolerant to peginterferon and ribavirin (n=235). Data will be presented at the European Association for the Study of the Liver meeting.

This half, the pharma plans to submit separate NDAs to FDA for daclatasvir, a selective HCV NS5A protein inhibitor, and asunaprevir, an HCV NS3 protease inhibitor. Last year, Bristol-Myers submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for an interferon- and ribavirin-free oral regimen of daclatasvir and asunaprevir to treat chronic HCV genotype 1b infection. ...