Achillion Begins Trial of New HCV Drug ACH-3102, Announces Fast Track Status
Achillion Pharmaceuticals, Inc., announced in May that it has begun a phase 1 clinical trial of ACH-3102. The new drug is being developed to treat chronic hepatitis C virus (HCV) infection. ACH-3102 is a second generation pan-genotypic (effective against all types of HCV) NS5A inhibitor.
According to Achillion, ACH-3102 is a “structurally distinct” small molecule compound that has demonstrated potent inhibition of the NS5A protein across all genotypes of HCV in preclinical studies. The NS5A protein directs production of virus particles, interacts with host proteins and is associated with interferon resistance.
The randomized phase 1 trial will enroll approximately 96 volunteers in the US to investigate the safety, tolerability and pharmacokinetic profile of ACH-3102. The trial will assess dosing in single and multiple ascending oral doses for up to 28 days.
“We believe that NS5A inhibitors, in combination with protease inhibitors, will play an integral role in achieving the goal of an all-oral interferon-free treatment regimen for all segments of the HCV infected patient population,” said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. “With our continued focus on compounds with potentially best-in-class characteristics, including safety and efficacy, broad genotypic effect with once-daily dosing and enhanced resistance profiles, we hope to move ACH-3102 through Phase 1 for HCV-infected subjects and toward combination studies with ACH-1625, our Phase 2 protease inhibitor, during the third quarter of 2012.”
In a separate news release on May 15, the company announced that ACH-3102 had received Fast Track Designation by the US Food and Drug Administration (FDA). This status means more frequent interactions with the FDA and the possibility of priority review, which could decrease the typical time needed for drug development and review.
Source: Achillion news releases dated May 9 and May 15, 2012