Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 ... (p The clinical plan to support an NDA ...)

Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data

Date:12/5/2007

The clinical plan to support an NDA approval for Sulonex(TM) under Subpart H (accelerated approval), as agreed upon with the FDA under an SPA, consists of: (i) a single Phase 3 trial in patients 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 patients 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 Sulonex(TM) versus placebo, with a 1:1 randomization between the two arms. The objective of this study is to determine the safety and efficacy of sulodexide in the treatment of patients 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 patients to be on treatment for six months, followed by two months of evaluation off-treatment.

During the treatment and off-treatment evaluation period, all patients in the study population are expected to continue to receive maximum approved or tolerated doses of ACEis or ARBs. Patients 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 microalbuminuria while the patients are treated with maximum approved or tolerated doses of ACEis or ARBs.

The primary endpoint for the Phase 3 clinical trial is "therapeutic success" at 6 months, where therapeutic success is defined as (i) conversion from microalbuminuria to normoalbuminuria, as measured by album
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SOURCE Keryx Biopharmaceuticals
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Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 ...(p The clinical plan to support an NDA ...),Health