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KERYX BIOPHARMACEUTICALS INITIATES PHASE III AND PHASE IV OF KRX-101

June 29, 2005

Keryx Biopharmaceuticals has announced the initiation of its pivotal Phase III and Phase IV clinical program with KRX-101 (oral sulodexide gelcap), the company's lead drug candidate, for the treatment of diabetic nephropathy.

This program is being conducted under the Subpart-H guidelines for accelerated approval pursuant to a Special Protocol Assessment (SPA) with the FDA.

The Phase III portion of the program 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 III study is designed to enroll approximately 1,000 patients and it is expected that it will take approximately 12-18 months to recruit for this study.

The Phase IV 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 Phase IV study is designed to enroll approximately 2,200 patients and it is expected that it will take approximately 24 months to recruit for this study.

The KRX-101 pivotal program 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.