Merck and Bristol-Myers Squibb to jointly study potential hepatitis C therapy

Work revolves around a Phase II clinical trial to evaluate regimen combining Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor daclatasvir and Merck's investigational NS3/4A protease inhibitor MK-5172

Jeffrey Bouley
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WHITEHOUSE STATION, N.J.—Merck & Co. recently announced that it has entered into a non-exclusive agreement withBristol-Myers Squibb Co. to conduct a Phase II clinical trial evaluating thesafety and efficacy of a once-daily oral combination regimen consisting of Bristol-Myers Squibb's investigational NS5A replication complex inhibitordaclatasvir and Merck's investigational NS3/4A protease inhibitor MK-5172 forthe treatment of chronic hepatitis C virus (HCV) infection, genotype 1.
"In HCV, agreements like this that combine novelinvestigational candidates are important to evaluate the potential of noveloral regimens early in the development cycle," said Dr. Eliav Barr, vicepresident, Infectious Diseases, Project Leadership and Management, MerckResearch Laboratories. "We are pleased to collaborate with Bristol-Myers Squibbto advance this potential all-oral combination." 
The planned initiation of the Phase II clinicaltrial follows the completion of a Phase I safety evaluation of theinvestigational combination regimen. Under the agreement, Merck will conductthe Phase II clinical trial. Further clinical development activities beyond thePhase II study are not covered as part of this agreement. Additional details ofthe collaboration were not disclosed.
MK-5172 is an investigational orally available HCVNS3/4A protease inhibitor currently being evaluated in combination with otherapproved and investigational medications in Phase II clinical trials. Thisincludes an all oral combination with MK-8742, Merck's investigational orallyavailable HCV NS5A protease inhibitor. 
Daclatasvir is an NS5A replication complex inhibitorthat is being extensively studied as a key component of potential direct-actingantiviral (DAA) based hepatitis C treatment regimens. Studied in more than4,100 patients to date, daclatasvir is in Phase III development.
SOURCE: Merck news release

Jeffrey Bouley

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