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KERYX REPORTS RESULTS FROM STUDY OF DIABETIC NEPHROPATHY THERAPY

December 16, 2005

Keryx Biopharmaceuticals has announced positive final efficacy results from its Phase II study of KRX-101 (sulodexide gelcaps) for the treatment of Type 2 diabetic nephropathy patients with persistent microalbuminuria.

In the study, two doses of KRX-101 (200 mg and 400 mg) were compared to placebo in patients with diabetic microalbuminuria on maximal therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker. Patients were treated with KRX-101 or placebo for six months and followed for an additional two months post-treatment. Patients were randomized 1:1:1, placebo, 200 mg and 400 mg of KRX-101, respectively.