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- Enrollment completed in pilot Phase 2a study of ACH-3102 and ribavirin for genotype 1b CC patients -
- Up to 12 weeks of once daily ACH-3102 appears safe and well tolerated with no on-treatment virologic breakthrough observed to date -- Profile of ACH-3102 supportive of continued development for genotype 1b and in combination with other direct-acting antivirals for the broad treatment of HCV -
NEW HAVEN, Conn., Jan. 7, 2013 (GLOBE NEWSWIRE) --
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that it has completed enrollment in a pilot Phase 2a trial evaluating ACH-3102, a second-generation pan-genotypic NS5A inhibitor, in combination with ribavirin for the treatment of patients with chronic genotype 1b (GT 1b) hepatitis C virus (HCV) infection. The initial cohort enrolled eight patients with GT 1b HCV, IL28b genotype CC, that are receiving twelve weeks of ACH-3102 once daily in combination with ribavirin.
To date, five patients have completed 4 weeks of treatment, including three patients who have completed 12 weeks of treatment. ACH-3102 has been well-tolerated by all patients with no serious adverse events, subject withdrawals, or on-treatment viral breakthrough reported to date. Treatment with ACH-3102 has resulted in rapid reduction in HCV RNA accompanied by normalization of liver enzymes.
"We are very pleased to see that the profile of ACH-3102 continues to exceed our expectations for providing a truly improved barrier to resistance. As the first-ever clinical trial to evaluate a NS5A inhibitor as a single direct-acting antiviral in combination with ribavirin, we are extremely encouraged by these initial results that demonstrate rapid suppression of the HCV GT1b virus and a well-tolerated safety profile through 12 weeks of therapy," commented Milind Deshpande, Ph.D., President of Research and Development and Chief Scientific Officer of Achillion. "As this data set continues to mature, we look forward to reporting initial SVR results at a medical meeting in the second quarter, and are planning to expand enrollment in the study to include non-CC GT 1b treatment-naïve patients later this quarter pending regulatory discussions."