Bristol-Myers Squibb Company and Pharmasset announced today
that the companies have entered into a clinical collaboration agreement to
evaluate the utility of BMS-790052, Bristol-Myers Squibb’s NS5A replication
complex inhibitor, in combination with PSI-7977, Pharmasset’s nucleotide
polymerase inhibitor, for the treatment of chronic hepatitis C virus (HCV).
“Bristol-Myers Squibb is committed to the goal of helping
patients prevail over hepatitis C by investigating multiple therapeutic
platforms”
This proof of concept study will evaluate the potential to
achieve sustained viral response 24 weeks post treatment with an oral,
once-daily treatment regimen in patients across HCV genotypes. Specifically,
the study will assess the safety, pharmacokinetics and pharmacodynamics of
BMS-790052 in combination with PSI-7977, with and without ribavirin, in
treatment-naïve patients chronically infected with HCV genotypes 1, 2, and 3.
The study is planned to start in the first half of 2011. This collaboration
represents the first cross-company collaboration combining two oral agents to
address a significant unmet medical need in the treatment of HCV.
“Bristol-Myers Squibb is committed to the goal of helping
patients prevail over hepatitis C by investigating multiple therapeutic
platforms,” said Brian Daniels, senior vice president, Development. “We are
pleased to partner with Pharmasset on this important study to advance the
scientific understanding of the potential for an all-oral regimen to treat
hepatitis C. Conducting this study highlights Bristol-Myers Squibb’s ability to
collaborate with other companies to develop innovative combination therapies in
areas of high unmet need.”
”We are excited to be working with Bristol-Myers Squibb and
to be investigating PSI-7977 with a different class of direct acting
antivirals,” stated Michelle Berrey, MD, MPH, Chief Medical Officer. “This
collaboration represents one of many approaches we are pursuing with our
portfolio of nucleoside/tide analogs that include both interferon free and
interferon sparing regimens. We believe the development of an all oral
treatment regimen represents an important evolution in the treatment of HCV.”
