Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Achillion Pharmaceuticals's ACH-1625 drug has been granted fast track designation by the US Food and Drug Administration (FDA), for the treatment of chronic hepatitis C virus (HCV).
Subscribe to our email newsletter
ACH-1625, a once-daily HCV protease inhibitor and an open chain, non-covalent NS3 protease inhibitor, is currently being evaluated in a Phase 2 clinical trial as a treatment for HCV.
The first segment of a Phase 2a clinical study randomized treatment-naïve genotype 1 HCV patients to 200 mg, 400 mg, or 800 mg doses of ACH-1625 in combination with pegylated interferon and ribavirin (SOC) and found a rapid viral response (RVR) of 75 to 81% compared to an RVR of 20% for patients receiving SOC only.
The randomized double-blind second cohort of the Phase 2a study evaluated the safety, tolerability and antiviral activity of once daily ACH-1625, at doses of 200 mg, 400 mg or 800 mg, in combination with SOC for 12 weeks of dosing.
Achillion president and CEO Michael Kishbauch said they look forward to begin an interferon-free, all-oral combination clinical study evaluating its protease inhibitor plus NS5A inhibitor for the treatment of HCV during the second half of 2012.
"We are very pleased with the granting of a Fast Track designation for ACH-1625, which we believe highlights this protease inhibitor’s attributes which include broad genotypic coverage of HCV, once-daily administration and an improved safety, efficacy and tolerability profile over currently approved therapies for HCV," Kishbauch added.