- In this study, adverse event profile of regimen containing BMS-790052 was consistent with that of treatment with peginterferon alfa and ribavirin plus placebo
- Company has initiated Phase III development program for BMS-790052
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase II clinical trial of 48 treatment-naive genotype 1 hepatitis C infected patients in which treatment with BMS-790052, an NS5A replication complex inhibitor, in combination with peginterferon alfa and ribavirin (pegIFNalfa/RBV) maintained undetectable viral load at 24 weeks post-treatment (SVR24) in 83% (60 mg), 83% (10 mg) and 42% (3 mg) of patients, compared with 25% of patients in the pegIFNalfa/RBV control group after 48 weeks of combination therapy. In this study, serious adverse events were reported in one patient (8.3%) from each of the BMS-790052 treatment groups and in zero patients from the control group. The data were reported today at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago. The investigational direct acting antiviral BMS-790052 is now in Phase III development.
“The hepatitis C treatment landscape is rapidly evolving and although there have been positive advances recently, there remains a need for additional therapies with a more favorable efficacy and safety profile,” said Stanislas Pol, MD, PhD, Professor of Hepatology at Université Paris V (René Descartes), Paris, France and head of the Hepatology unit at Cochin Hospital, Paris, France. “In this Phase II study, adding BMS-790052 once daily to peginterferon alfa and ribavirin produced SVR rates and safety findings that warranted further development of BMS-790052.”
BMS-790052 plus pegIFNalfa/RBV achieved higher rates of SVR24 compared to pegIFNalfa/RBV alone across all BMS-790052 treatment groups [BMS-790052: 60 mg: 83% (n=10/12), 10 mg: 83% (10/12), 3 mg: 42% (5/12); control: 25% (3/12)].
Adverse events (AEs) leading to discontinuation with BMS-790052 plus pegINFalfa/RBV were comparable with treatment with pegIFNalfa/RBV plus placebo. One patient (8.3%) in each of the 3 mg and 10 mg groups and four patients (33.3%) in the 60 mg group discontinued due to AEs, compared with two patients (16.7%) in the control group. Reasons for discontinuation were a diverse set of AEs sometimes associated with the use of pegIFNalfa/RBV.
Serious adverse events (SAEs) and overall AEs were comparable across study arms. The addition of BMS-790052 to pegIFNalfa/RBV therapy did not result in any apparent incremental hematologic, hepatic or dermatologic adverse events. One patient (8.3%) in each of the BMS-790052 treatment groups experienced a SAE during therapy compared with zero patients in the control group. On-treatment Grade 3-4 AEs were: BMS-790052 60 mg: 33.0%, 10 mg: 25.0%, 3 mg: 8.3%; control: 41.7%. One patient (8.3%) in each of the BMS-790052 3 mg and 60 mg groups experienced hemoglobin <10 g/dL, compared with zero patients in the 10 mg and control groups. AEs occurring in at least four patients (33.3%) in any cohort were consistent across BMS-790052 treatment arms and the placebo arm, and included the following events of interest: anemia (BMS-790052: 60 mg: 50.0%,10 mg: 41.7%, 3 mg: 25.0%; control: 41.7%), nausea (BMS-790052: 60 mg: 33.3%,10 mg: 33.3%, 3 mg: 41.7%; control: 50.0%), vomiting (BMS-790052 60 mg: 33.3%, 10 mg: 8.3%, 3 mg: 16.7%; control: 0%), neutropenia (BMS-790052: 60 mg: 16.7%,10 mg: 33.3%, 3 mg: 25.0%; control: 41.7%), and rash (BMS-790052: 60 mg: 16.7%,10 mg: 33.3%, 3 mg: 33.3%; control: 25.0%).
Erythropoietin use was comparable across all study arms. Three patients (25.0%) in each of the BMS-790052 10 mg and 60 mg groups and one patient (8.3%) in the 3 mg group required erythropoietin, compared with two patients (16.7%) in the control group. The use of filgrastim (G-CSF) in the study groups was: BMS-790052 60 mg: 0%, 10 mg: 25.0%, 3 mg: 16.7%; control: 16.7%.
About the Study
This double-blind study randomized 48 treatment-naïve HCV genotype 1-infected, non-cirrhotic patients 1:1:1:1 (n=12/arm) to receive one of three doses of BMS-790052 (3 mg, 10 mg, or 60 mg) or placebo once daily, in combination with peginterferon alfa-2a and ribavirin for 48 weeks. The primary endpoint of the study was the proportion of patients with extended rapid virologic response (eRVR), defined as undetectable viral load (HCV RNA < 10 IU/mL) at both Weeks 4 and 12. Primary endpoint data were previously reported at EASL 2010 in Vienna, Austria.
Discovered by Bristol-Myers Squibb through a genomics approach, BMS-790052 is the first NS5A replication complex inhibitor to be investigated in HCV clinical trials and is currently in Phase III development. BMS-790052 is part of a portfolio of investigational compounds that the company is developing for the treatment of hepatitis C.
About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. An estimated 170 million people worldwide are infected with hepatitis C. Up to 90 percent of those infected with hepatitis C will not clear the virus and will become chronically infected. Twenty percent of people with chronic hepatitis C will develop cirrhosis and, of those, up to one quarter may progress to liver cancer. Although there is no vaccine to prevent hepatitis C, it is a potentially curable disease.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that clinical trials of this compound will support a regulatory filing, or that the compound will receive regulatory approval or, if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2010, in our Quarterly Reports on Form 10-Q, and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
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INDUSTRY KEYWORDS: Health Infectious Diseases Pharmaceutical