Enanta Announces Eight Weeks Of Treatment With AbbVie's Investigational, Pan-Genotypic Regimen Of Glecaprevir/Pibrentasvir (G/P) Achieved High SVR Rates Across All Major Genotypes Of Chronic Hepatitis C
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that AbbVie has published high SVR 12 rates across all major chronic hepatitis C virus (HCV) genotypes with 8 weeks of treatment with its investigational, pan-genotypic regimen consisting of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P). In more than 700 chronic HCV patients without cirrhosis who were infected with one of genotypes 1-6 (GT1-6) and were new to treatment, 97.5 percent (n=693/711) achieved sustained virologic response at 12 weeks post treatment (SVR 12), regardless of baseline viral load. The rate of virologic failure was 1 percent (n=9/711). Glecaprevir (GLE), an NS3/4A protease inhibitor, is Enanta's second protease inhibitor being developed through its collaboration with AbbVie. G/P is a once-daily regimen that combines two distinct antiviral agents. G/P is a fixed-dose combination of glecaprevir (300mg) and pibrentasvir (120mg), an NS5A inhibitor, dosed once-daily as three oral tablets. These new top-line data comprise results from the eight week arms of three registrational clinical trials evaluating the efficacy and safety of G/P - the ENDURANCE-1, ENDURANCE-3 and SURVEYOR-2 (Part 4) studies. Across the eight week arms of all three studies, there were no discontinuations due to adverse events (AEs). The most common AEs, occurring at a rate greater than 10 percent across these arms were headache and fatigue; and there were no AEs in any study arm at a rate greater than 20 percent. No clinically relevant laboratory abnormalities, including ALT changes, were observed. "The SVR rates in these studies are an important step toward providing an 8-week treatment option to HCV-infected patients without cirrhosis who are new to treatment," commented Jay R. Luly, Ph.D. "We look forward to AbbVie's regulatory approval filings planned in the U.S. by the end of this year and in Europe and Japan in early 2017."