Enanta Pharmaceuticals Inc (ENTA)

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Enanta Pharmaceuticals Announces 96 Percent SVR12 in Treatment Experienced Genotype 1 Hepatitis C Patients in SAPPHIRE-II Study
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Today : Tuesday 10 December 2013
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- Second of Six All-Oral, Interferon-Free Phase 3 Hepatitis C Studies Using Regimen Containing ABT-450

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) today announced results from the SAPPHIRE-II study, the second of six phase 3 registrational studies being conducted by AbbVie for the treatment of hepatitis C virus (HCV) genotype 1 (GT1) infection, using a regimen containing Enanta’s lead protease inhibitor ABT-450. ABT-450 is part of AbbVie’s investigational three direct-acting antiviral (3D) regimen, consisting of boosted protease inhibitor ABT-450/ritonavir, NS5A inhibitor ABT-267, and non-nucleoside polymerase inhibitor ABT-333. The SAPPHIRE-II study used this 3D regimen plus ribavirin.

Results from the 394-patient SAPPHIRE-II trial demonstrated a sustained virologic response at 12 weeks post-treatment (SVR12) of 96 percent in chronically infected GT1 HCV treatment experienced adult patients who had previously failed pegylated interferon and ribavirin treatment. Approximately 49 percent of these patients were prior null responders, namely patients defined as not achieving a significant reduction in the HCV virus during their prior treatment. The majority of patients were GT1a, considered the more difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 96 percent and 97 percent, respectively. These results were based on an intent-to-treat analysis and were achieved after 12 weeks of treatment. Virologic relapse or breakthrough was noted in 2 percent of patients receiving the 3D regimen plus ribavirin. The treatment regimen was well tolerated, with 1 percent of patients discontinuing treatment due to adverse events.

“The high SVR rates in this SAPPHIRE-II trial and the previously reported SAPPHIRE-I trial further validate this 3D regimen plus ribavirin for both treatment-naive and treatment-experienced patients,” stated Jay R. Luly, Ph.D., President and Chief Executive Officer. “We look forward to the remaining phase 3 studies reading out using the same 3D regimen with and without ribavirin, as well as in the treatment of HCV patients with cirrhosis.”

About Study M13-098 (SAPPHIRE-II)

Following SAPPHIRE-I, SAPPHIRE-II is the second placebo-controlled trial and the second of six phase 3 trials supporting AbbVie’s investigational 3D regimen for the treatment of GT1 hepatitis C patients. AbbVie will disclose detailed SAPPHIRE-II results at future scientific congresses and in publications.

SAPPHIRE-II is a global, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 12 weeks of treatment with ABT-333 (250mg), ribavirin (weight-based), both dosed twice daily, and the fixed-dose, co-formulated combination of ABT-450/ritonavir (150/100mg) and ABT-267 (25mg) dosed once daily in non-cirrhotic, GT1a and GT1b HCV-infected, treatment-experienced adult patients who previously failed treatment with pegylated interferon and ribavirin.

The study population consisted of 394 GT1 treatment-experienced patients with no evidence of liver cirrhosis. 297 patients were randomized to the 3D regimen plus ribavirin for 12 weeks, and 97 patients were randomized to placebo for the initial 12 weeks. Patients initially randomized to placebo for the first 12 weeks then received open-label treatment with the 3D regimen plus ribavirin for 12 weeks. In the study, 49 percent of patients were prior null responders to pegylated interferon and ribavirin, generally considered among the most difficult to treat successfully.

Following 12 weeks of treatment with AbbVie’s 3D regimen plus ribavirin, 96 percent (n=286/297) of patients achieved SVR12 based on an intent-to-treat analysis, where patients with missing values for any reason were considered treatment failures. The SVR12 rates in GT1a and GT1b patients were 96 percent (166/173) and 97 percent (119/123), respectively. One subject had HCV genotype 1 and achieved SVR12, but was unable to be sub-genotyped.

The most commonly reported adverse events in both the 3D and placebo arms were headache, fatigue and nausea. Discontinuations due to adverse events were reported in three (1 percent) patients receiving the 3D regimen and no patients receiving placebo. Virologic relapse or breakthrough was noted in 2 percent of patients receiving the 3D regimen plus ribavirin.

AbbVie has announced that results from the remaining four ABT-450 containing studies in AbbVie’s phase 3 program will be available in the coming months