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Keryx Biopharmaceuticals Completes SUN-MICRO Phase 3 Pivotal Trial
Date:2/11/2008

BOUT THE SULONEX (sulodexide oral gelcap) PHASE 3 and PHASE 4 CLINICAL PROGRAM

Sulodexide is in a pivotal Phase 3 and Phase 4 clinical program under a Special Protocol Assessment with the Food and Drug Administration. These trials are being conducted by the Collaborative Study Group, the world's largest standing renal clinical trials group.

The clinical plan to support an NDA approval for sulodexide under Subpart H (accelerated approval), as agreed upon with the FDA under an SPA, consists of: (i) a single Phase 3 trial in subjects with microalbuminuria based on the surrogate marker of regression of microalbuminuria as the primary endpoint; (ii) supportive data from previously conducted clinical studies; and (iii) substantial recruitment into our Phase 4 confirmatory study that will measure clinical outcomes in subjects with overt nephropathy, or macroalbuminuria.

The Phase 3 clinical program is a multi-center, randomized, double-blind, placebo-controlled study, comparing 200 mg daily of sulodexide versus placebo, with a 1:1 randomization between the two arms. The objective of this study is to evaluate the safety and efficacy of sulodexide in subjects with type 2 diabetes and persistent microalbuminuria, or diabetic nephropathy, despite being treated with a maximum approved or tolerated dose of an angiotensin II receptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEi). The study is designed for subjects to be on drug for six months, followed by two months of evaluation off-drug.

During the drug and off-drug evaluation period, all subjects in the study population are expected to continue to receive maximum approved or tolerated doses of ACEis or ARBs. Subjects who were not already on maximum approved or tolerated doses of ACEis or ARBs for 120 days were required to go into a run- in period prior to randomization of up to 120 days. This run-in period was designed to stabilize blood pressure and to confirm persistent microalbu
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SOURCE Keryx Biopharmaceuticals
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