Keryx Biopharmaceuticals, Inc. has initiated its pivotal Phase 3 and Phase 4 clinical programme with KRX-101 (oral sulodexide gelcap), the Company's lead drug candidate, for the treatment of diabetic nephropathy. This programme is being conducted under the Subpart-H guidelines for accelerated approval pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA).
The Phase 3 portion of the programme is a randomized, double-blind, placebo-controlled study comparing 200 mg daily of KRX-101 versus placebo, with a 1:1 randomization between the two arms, in patients with persistent microalbuminuria. The Phase 4 portion of the program, which is also being initiated, is a randomized, double-blind, placebo-controlled study, also comparing 200 mg daily of KRX-101 versus placebo, with a 1:1 randomization between the two arms, in patients with persistent macroalbuminuria or overt nephropathy.
The KRX-101 pivotal programme is being conducted by The Collaborative Study Group (CSG), the world's largest standing renal clinical trial group, whose execution of the angiotensin-converting enzyme (ACE) inhibition trial of captopril in Type 1 diabetic nephropathy and the angiotensin II receptor blocker (ARB) trial of irbesartan in Type 2 diabetic nephropathy (I.D.N.T. study) both led to FDA approval and the recommendation of these agents as standards of care by the American Diabetes Association.
Participating in the KRX-101 studies are over 250 US, European and Asian-Pacific clinical centres.