Bristol-Myers Squibb: BMS-790052 (NS5A inhibitor)
 
Pipeline Asset Update for BMS-790052
(NS5A inhibitor)
Pipeline Asset: BMS-790052, an NS5A inhibitor under investigation for the treatment of hepatitis C virus (HCV) infection
Current Phase of Development: Phase 2
Meeting or Publication: European Association for the Study of the Liver (EASL) 2010
Study Title: Once-Daily NS5A Inhibitor (BMS-790052) Plus Peginterferon-Alpha-2A and Ribavirin Produces High Rates of Extended Rapid Virologic Response in Treatment-Naïve HCV-Genotype 1 Subjects: Phase 2A Trial
Abstract Number: N/A
Date/Time of Presentation: Saturday, April 17, 2010 at 5 p.m. CET / 11 a.m. EDT
Media Embargo: Per EASL press guidelines, this oral presentation is under embargo until the conclusion of the Late-Breaker Session on Saturday, April 17, 2010 from 4 – 6 p.m. CET / 10 a.m. – 12 p.m. EDT.
Primary Study Objective: To assess the safety and antiviral activity of three different doses of BMS-790052 (3 mg, 10 mg and 60 mg) in patients with chronic genotype 1 HCV infection.
Study Conclusion:
  • BMS-790052 yielded higher rates of extended rapid virologic response (eRVR), rapid virologic response (RVR) and complete early virologic response (cEVR) when combined with peginterferon and ribavirin compared to peginterferon and ribavirin alone.
  • The rate of adverse events was comparable across BMS-790052 dosing arms and placebo.
  • These results support further development of BMS-790052 in combination with peginterferon and ribavirin or other HCV antivirals.
Efficacy Results: The proportion of patients in each dosing arm that achieved eRVR at weeks 4 and 12 (primary endpoint), RVR at week 4 and cEVR at week 12 was:
  • BMS-790052 3 mg: 42% , 42% and 58%, respectively
  • BMS-790052 10 mg: 83%, 92% and 83%, respectively
  • BMS-790052 60 mg: 75%, 83% and 83%, respectively
  • Placebo: 8%, 8% and 42%, respectively
Adverse Events:
  • Adverse events were consistent with those commonly observed with peginterferon and ribavirin.
  • There was one serious adverse event (SAE) in each BMS-790052 dose group and seven Grade 3-4 adverse events (AEs) on treatment. The Grade 3-4 AEs were distributed as follows:
    • 1 on BMS-790052 3 mg
    • 1 on BMS-790052 10 mg
    • 2 on BMS-790052 60 mg
    • 3 on placebo
  • There were four AEs leading to discontinuation across the treatment arms.
    • 1 on BMS-790052 3 mg
    • 0 on BMS-790052 10 mg
    • 2 on BMS-790052 60 mg
    • 1 on placebo
BMS-790052 Background:
  • BMS-790052 is an investigational first-in-class, highly-selective oral hepatitis C NS5A inhibitor. NS5A is an essential component for hepatitis C virus replication.
  • BMS-790052 is one of several small molecules Bristol-Myers Squibb is studying for the potential treatment of hepatitis C. This portfolio of investigational compounds to treat hepatitis C fits into the company's overall R&D focus on diseases where there is major unmet medical need.
Study Background:
  • Double-blind, placebo-controlled, phase 2a study
  • 48 study subjects were randomized 1:1:1:1 to receive 3 mg, 10 mg or 60 mg of study drug or placebo
  • Inclusion Criteria:
    • 18 to 70 years of age
    • HCV genotype 1
    • HCV RNA viral load of ≥ 100,000 IU/mL at screening
    • Treatment-naive
  • Exclusion Criteria:
    • Women of child-bearing potential
    • Cirrhosis
    • Co-infection with HIV or hepatitis B virus
Request for More Information and Media Interviews: Investors: John Elicker, 609-252-4611, john.elicker@bms.com
Media: Carrie Fernandez, 609-252-4831, carrie.fernandez@bms.com
Supporting information: The abstract can be viewed on the EASL website.
 
 
 
 


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