Market Overview

Bristol-Myers Squibb's Investigational Hepatitis C Compounds Lambda and Daclatasvir Plus Ribavirin Achieved SVR12 in 93% of Genotype 1b Treatment-Naive Patients In Phase IIb Study

* First presentation of interim data on Lambda in combination with the direct-acting antiviral (DAA) daclatasvir, from the global D-LITE study of genotype 1 patients * Data from a separate Phase IIb study, EMERGE, continue to demonstrate comparable SVR24 rates and further illustrate the safety and tolerability profile of Lambda vs. alfa interferon in genotype 1 and 4 patients * Phase III development of Lambda in combination with other antivirals underway, and in combination with daclatasvir and ribavirin to initiate in 2013

Bristol-Myers Squibb Company (NYSE: BMY) today announced for the first time interim results from the global, D-LITE Phase IIb study, in which a 24-week regimen combining the investigational compound Peginterferon lambda-1a (Lambda) with the investigational direct-acting antiviral (DAA) daclatasvir (DCV) and ribavirin (RBV), achieved sustained virologic response 12 weeks post-treatment (SVR[12]) in 93% (13/14) of treatment-naïve, genotype 1b chronic hepatitis C patients who achieved a protocol-defined response (PDR)^1. The SVR12 rate for all genotype 1 infected patients in the Lambda/RBV/DCV group was 76% (28/37). These study findings were presented in a late breaker presentation at the American Association for the Study of Liver Diseases (AASLD) congress in Boston. The Company also presented SVR[4] results from the D-LITE Japanese sub-study, where all subjects were infected with HCV genotype 1b and SVR[12 ]was 100%. SVR results from the EMERGE Phase IIb study of Lambda versus alfa interferon (alfa) in treatment-naïve genotype 1 or 4 patients were also presented.

Posted-In: News FDA

 

Most Popular

Related Articles (BMY)

Around the Web, We're Loving...

Partner Network

Get Benzinga's News Delivered Free