ENANTA PHARMACEUTICALS ANNOUNCES PRELIMINARY DATA FROM ABBVIE’S PHASE 3B RUBY-I STUDY IN CHRONIC HEPATITIS C PATIENTS WITH RENAL IMPAIRMENT PRESENTED AT THE INTERNATIONAL LIVER CONGRESS™ 2015
In preliminary data from RUBY-I, patients receiving VIEKIRAX + EXVIERA with or without ribavirin who reached post-treatment week four (n=10 of 20 enrolled) achieved 100 percent sustained virologic response at four weeks post-treatment (SVR4)1
Treatment regimen evaluating VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV) contains Enanta’s lead protease inhibitor, paritaprevir
WATERTOWN, Mass.--(BUSINESS WIRE)--Apr. 25, 2015-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced today new preliminary safety and efficacy data from the first cohort of AbbVie’s ongoing, Phase 3b RUBY-I study. RUBY-I is evaluating the regimen of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) with or without ribavirin (RBV) in treatment-naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis. The primary endpoint of the study is the percentage of patients achieving sustained virologic response at 12 weeks post-treatment (SVR12). The first ten patients, or 100 percent, who have reached post-treatment week four to date (n=10 of 20 enrolled) achieved SVR4 (n=10/10).1 The RUBY-I study was presented as a late-breaker today at The International Liver Congress™ (ILC) 2015, the 50th annual meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.
“We are encouraged by this promising data in this difficult-to-treat patient population,” stated Jay R. Luly, Ph.D., President and Chief Executive officer. “We look forward to the final data from this and other studies that AbbVie is conducting in special populations.”
RUBY-I data showed no virologic failures to date.1 Preliminary safety analyses reported that patients experienced mainly mild or moderate adverse events when receiving VIEKIRAX + EXVIERA with or without RBV, most commonly (> 20 percent) anemia, fatigue, diarrhea, nausea, dizziness and headache.1 To date, eight of 13 GT1a patients had a RBV dose interruption.1
Paritaprevir, Enanta’s lead protease inhibitor, is one of the three direct-acting antivirals (DAAs) included in AbbVie’s HCV treatment regimens approved in the U.S. for genotype 1 chronic hepatitis C virus as VIKIERA PAK®, in the E.U. as VIEKIRAX® + EXVIERA®, and in Canada as HOLKIRA PAK®. AbbVie is responsible for all development and commercialization activities for regimens that contain paritaprevir.
Additional Phase 3b studies from AbbVie presented at ILC 2015 included MALACHITE-I and MALACHITE-II data, and TOPAZ-I and TOPAZ-II study design. The MALACHITE studies evaluate adult patients with GT1 chronic HCV infection without cirrhosis receiving VIEKIRAX + EXVIERA with or without RBV compared to treatment with telaprevir with pegylated-interferon and RBV, which remains the standard of care in many regions of the world.2,3 The TOPAZ studies will evaluate the effect of SVR12 on long-term outcomes five years following treatment with VIEKIRAX + EXVIERA with or without RBV in adults with GT1 chronic HCV infection.4
