Achillion Pharmaceuticals Inc., an innovative pharmaceutical focused on solutions against infectious disease including hepatitis C and resistant bacterial infections, today announced top-line results from its on-going phase 2a clinical trial of ACH-1625 dosed once daily in combination with Pegasys(R) and Copegus(R) a current standard of care (SOC) in patients with chronic hepatitis C (HCV) infection.
The first of a two-segment phase 2a trial involved 64 patients administered three doses of ACH-1625 or placebo with peginterferon alfa-2a and ribavirin, dosed for a four-week study. The analysis demonstrated that 75-81 percent of patients receiving ACH-1625 achieved rapid virologic response (RVR) with a promising safety and tolerability profile; all patients receiving four weeks of treatment with ACH-1625 demonstrated continuous and substantial declines in HCV RNA with no viral breakthrough during therapy at any of the doses.
After the four weeks of ACH-1625 administration, patients were treated with SOC, in which there were no discontinuations due to adverse events and there were no serious adverse events (SAEs) reported.
“These data reflect a positive outcome with high RVR, irrespective of IL28B status, which places ACH-1625 among the most potent protease inhibitors in development,” Elizabeth A. Olek, M.D., vice president and chief medical officer of Achillion stated in the press release. Dr. Olek said the company will select two of the doses and commence the second segment of the trial, dosing ACH-1625 with SOC over 12 weeks.
“We are quite pleased with the continued robust efficacy results and good safety profile with once-daily doses of ACH-1625,” Michael D. Kishbauch, Achillion’s president and CEO stated. “ACH-1625 continues to demonstrate best-in-class features, including once-daily dosing, robust antiviral activity, coupled with safety and tolerability for patients. These attributes distinguish our drug and suggest it could offer improvements over other next-generation protease inhibitors that will reach the market mid-decade.”
The company noted that in phase 1a clinical studies ACH-1625 was well tolerated at all doses and there were no SAEs, and no clinically significant changes in vital signs, electrocardiograms or laboratory evaluations. In phase 1b clinical studies, HCV-infected patients receiving doses showed mean maximal reductions in viral load.
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