EASL - Merck To Present New Data for MK-8742 and MK-5172

Merck's new PhIII hep C program may help repair a damaged R&D rep

March 25, 2014 | By John Carroll

 In a matter of weeks Merck plans to move a closely-watched combination treatment for hepatitis C into a Phase III trial. The move will boost Merck's late-stage pipeline to 13 programs, giving new R&D chief Roger Perlmutter some additional evidence to back up a case that the leviathan outfit has finally shaken off the lethargy that led to a years-long drought of significant approvals, focusing on pioneering therapies that can carve out badly needed revenue.

Merck announced the move as it prepared to unveil a new round of high cure rates found among genotype 1 patients taking a combination of MK-5172 and MK-8742, a pair of drugs that the FDA picked for its breakthrough drug program, offering a potentially shorter path to the market.
"These additional clinical data for MK-5172 and MK-8742 build upon the clinical evidence collected to date across a broad spectrum of patients with chronic HCV," said Dr. Eliav Barr, the vice president for infectious disease at Merck Research Laboratories, in a statement. "Based on these data, we are pursuing a Phase III clinical program for these potentially important investigational medicines.........

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Merck to Present New Data for Investigational Hepatitis C Treatments MK-5172 and MK-8742 at EASL Annual Meeting/The International Liver Congress™ 2014

Company to Initiate Phase 3 Clinical Development Program in Q2 2014

Read more here: http://www.heraldonline.com/2014/03/24/5798673/merck-to-present-new-data-for.html?sp=/100/773/385/#storylink=cpy

WHITEHOUSE STATION, N.J. — Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that new Phase 2 data for its two investigational hepatitis C virus (HCV) treatments - MK-5172, an investigational HCV NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor – are scheduled to be presented at the 49^th Annual Meeting of the European Association for the Study of the Liver (EASL), also known as The International Liver Congress™ 2014. The data are from Merck’s overall Phase 2 clinical program. The meeting will take place in London, United Kingdom, April 9 - 13, 2014.

Based on the results of the Phase 2 program, Merck is initiating a Phase 3 clinical trial program, to be named C-EDGE. The C-EDGE program is designed to evaluate these investigational treatments across genotypes and in different HCV subpopulations, including patients with chronic kidney disease, HIV/HCV co-infection, and cirrhosis.

“These additional clinical data for MK-5172 and MK-8742 build upon the clinical evidence collected to date across a broad spectrum of patients with chronic HCV,” said Dr. Eliav Barr, vice president, Infectious Disease, Merck Research Laboratories. “Based on these data, we are pursuing a Phase 3 clinical program for these potentially important investigational medicines.”
In October 2013, Merck announced that the U.S. Food and Drug Administration granted Breakthrough Therapy designation to the investigational combination MK-5172/MK-8742 for treatment of chronic HCV infection.

Selected Presentations for MK-5172/MK-8742:

• Efficacy and Safety of MK-5172 and MK-8742 ± Ribavirin in Hepatitis C Genotype 1 Infected Patients with Cirrhosis or Previous Null-Response: The C-WORTHY Study. Lawitz, E. et al. Oral presentation #O61: April 11, 2014, 4:00-4:15 p.m. BST.
• Efficacy and Safety of the All-Oral Regimen, MK-5172/MK-8742 ± RBV for 12 Weeks in GT1 HCV/HIV Co-infected Patients: The C-WORTHY Study. Sulkowski, M. et al. Oral presentation #O63: April 11, 2014, 4:30-4:45 p.m. BST.
• Safety and Efficacy of the All-Oral Regimen of MK-5172/MK-8742 ± Ribavirin in Treatment-naïve, Non-cirrhotic Patients with Hepatitis C Virus Genotype 1 Infection: The C-WORTHY Study. Hezode, C et al. Oral Presentation #O10: April 10, 2014, 4:45-5:00 p.m. BST.

Merck’s Commitment to HCV
For more than 25 years, Merck has been at the forefront of the response to the HCV epidemic, and has helped to make a difference through our proud legacy of commitment to innovation, collaborating with the community, and expanding global access to medicines. Merck is dedicated to applying our scientific expertise, resources and global reach to deliver healthcare solutions that support people living with HCV worldwide.

Read more here: http://www.heraldonline.com/2014/03/24/5798673/merck-to-present-new-data-for.html?sp=/100/773/385/#storylink=cpy