This milestone officially marks the completion of the pivotal clinical trial of its investigational drug Sulonex (sulodexide oral gelcap) in the treatment of subjects with type 2 diabetes and persistent microalbuminuria despite treatment with the maximum approved or tolerated dose of either an Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). This randomized, double-blind, placebo-controlled study enrolled 1,056 subjects at over 150 sites worldwide.
The company anticipates top-line results from this study before the end of March 2008 and is targeting an NDA filing before year end. The company has committed to the FDA, as a condition to the accelerated approval of sulodexide based on the Phase III clinical trial, that the Phase IV study would be substantially enrolled at the time of the filing of the NDA for sulodexide.
Michael Weiss, chairman and CEO of Keryx, said: “The completion of the Sulonex Phase III clinical program is an important and significant milestone for Keryx.”