ACH-3102 Receives Fast Track Designation From The FDA For The Treatment Of Chronic Hepatitis C (ACHN)

ACH-3102 Receives Fast Track Designation From The FDA For The Treatment Of Chronic Hepatitis C (ACHN)

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections.

The Company announced that it has received 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."

President and Chief Executive Officer of Achillion Michael Kishbauch commented,

"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. 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."