Merck Enters Agreement with Bristol-Myers Squibb to Conduct a Phase II Clinical Trial Evaluating Combination of Investigational Oral Candidates MK-5172 and Daclatasvir for Chronic Hepatitis C
WHITEHOUSE STATION, N.J. -- 4/22/13
Merck (NYSE:MRK) today announced it has entered into a non-exclusive agreement with Bristol-Myers Squibb to conduct a Phase II clinical trial to evaluate the safety and efficacy of a once-daily oral combination regimen consisting of Bristol-Myers Squibb's investigational NS5A replication complex inhibitor daclatasvir and Merck's investigational NS3/4A protease inhibitor MK-5172 for the treatment of chronic hepatitis C virus (HCV) infection, genotype 1.
"In HCV, agreements like this that combine novel investigational candidates are important to evaluate the potential of novel oral regimens early in the development cycle," said Eliav Barr M.D., vice president, Infectious Diseases, Project Leadership and Management, Merck Research Laboratories. "We are pleased to collaborate with Bristol-Myers Squibb to advance this potential all-oral combination."
The planned initiation of the Phase II clinical trial follows the completion of a Phase I safety evaluation of the investigational combination regimen. Under the agreement, Merck will conduct the Phase II clinical trial. Further clinical development activities beyond the Phase II study are not covered as part of this agreement. Additional details of the collaboration were not disclosed.
MK-5172 is an investigational orally available HCV NS3/4A protease inhibitor currently being evaluated in combination with other approved and investigational medications in Phase II clinical trials. This includes an all oral combination with MK-8742, Merck's investigational orally available HCV NS5A protease inhibitor.
Merck's Global Commitment to Development of Hepatitis Therapies
Merck is committed to building on its strong legacy in the field of viral hepatitis by continuing to discover, develop and deliver vaccines and medicines to help prevent and treat viral hepatitis. In hepatitis C, company researchers developed the first approved therapy for chronic HCV in 1991 and the first combination therapy in 1998. In addition to ongoing studies for our marketed and investigational medicines for the treatment of chronic HCV, extensive research efforts are underway to develop additional oral therapies for viral hepatitis treatment.
Daclatasvir is an NS5A replication complex inhibitor that is being extensively studied as a key component of potential direct-acting antiviral (DAA) based hepatitis C treatment regimens. Studied in more than 4,100 patients to date, daclatasvir is in Phase III development.
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