US-based pharmaceutical firm Merck has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational oral combination regimen MK-5172/MK-8742 for the treatment of chronic hepatitis C virus (HCV) infection.
Merck's MK-5172/MK-8742 consists of MK-5172, an investigational HCV NS3/4A protease inhibitor and MK-8742, an investigational HCV NS5A replication complex inhibitor.
The company will release the interim data from an ongoing Phase IIB clinical trial at the 64th American Association for the Study of Liver Disease Annual Meeting, Washington D.C., to be held from 1-5 November 2013.
The Phase IIB clinical trial is designed to assess MK-5172/MK-8742 in genotype 1 infected patients (C-WORTHY Study).
Merck Research Laboratories president Roger Perlmutter said the designation of MK-5172/MK-8742 as a Breakthrough Therapy for chronic hepatitis C is an important milestone for the company.
"There remains significant unmet medical need in hepatitis C, and we are looking forward to working with the FDA to advance this program as quickly as we can to bring this investigational combination to HCV specialists and their patients," Perlmutter said.
The Breakthrough Therapy designation will help the company in accelerating the development and review of the drug candidate that is planned for use, alone or in combination for the treatment of serious or life-threatening disease or condition, according to the FDA.
Currently, MK-5172 and MK-8742 are being tested in several studies in patients with multiple HCV genotypes who are treatment-naive, treatment failures as well as other important HCV subpopulations such as patients with cirrhosis and those co-infected with HIV.
