Achillion Pharmaceuticals Inc. announced the receipt of a Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV). ACH-3102 is a pan-genotypic second-generation NS5A inhibitor against HCV that was discovered by Achillion and is currently being evaluated in a Phase 1 clinical trial.
Fast Track designation was requested for ACH-3102 for its potential to provide:
•Improved safety as compared to the current standard of care;
•Potential for development in a once daily interferon-free fixed dose combination;
•Potent antiviral activity in vitro against HCV genotypes 1 through 6;
•Low potential for drug-drug interactions and therefore greater potential to treat HCV patients with comorbidities, co-infected with HIV, or pre-
or post-liver transplantation.
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. Furthermore, the unique chemical structure of ACH-3102 has resulted in enhanced potency in vitro against resistant mutants that have emerged during clinical studies with first generation NS5A inhibitors.
“We are very pleased with the granting of a Fast Track designation for ACH-3102, which we believe highlights this second-generation NS5A inhibitor’s attributes that include pan-genotypic coverage of HCV and potential for maintained activity against NS5A mutant strains of HCV,”
commented Michael Kishbauch, President and Chief Executive Officer of Achillion. “We are excited to leverage the superior profile of ACH-3102 in combination with our Phase 2 protease inhibitor, ACH-1625, as we seek to create an optimized, potentially best-in-class potent, well-tolerated, once-daily regimen to treat HCV, which will enter combination studies during the third quarter of this year.”
Under the FDA Modernization Act of 1997, the Fast Track program facilitates interactions with the FDA before and during the submission of a New Drug Application (NDA) for therapeutics being investigated as a treatment of serious or life-threatening diseases which demonstrate the potential to address an unmet medical need for such a condition.
The Fast Track program enables a company to file an NDA on a rolling basis as data becomes available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA and the possibility of a priority review, which could decrease the typical development time and review period.
Date: May 15, 2012
Source: Achillion Pharmaceuticals Inc.
Filed Under: Drug Discovery