NEW YORK, Feb. 11 Keryx Biopharmaceuticalsannounced today that the last subject randomized into the SUN-Micro Phase 3clinical trial has completed their scheduled 8 month visit. This milestoneofficially marks the completion of this pivotal clinical trial of itsinvestigational drug Sulonex(TM) (sulodexide oral gelcap) in the treatment ofsubjects with type 2 diabetes and persistent microalbuminuria despitetreatment with the maximum approved or tolerated dose of either an AngiotensinConverting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB).This randomized, double-blind, placebo-controlled study enrolled 1,056subjects at over 150 sites worldwide.
The Company anticipates being able to report top-line results from thisstudy before the end of March 2008, and expects that the Collaborative StudyGroup will make a comprehensive scientific presentation of the data at amedical conference in the 2nd or 3rd quarter. The Company is targeting an NDAfiling before year end.
"The completion of the Sulonex Phase 3 clinical program is an importantand significant milestone for Keryx," stated Michael S. Weiss, Chairman andCEO of the Company, who continued, "We recognize and are grateful for thededication, diligence and compliance exhibited by the Collaborative StudyGroup and the more than 1,000 patients who participated in what is consideredto be the largest ever randomized study for type 2 diabetic patients withpersistent microalbuminuria."
Commenting on the news, Edmund J. Lewis, MD, co-Principal Investigator ofthe Phase 3 Study remarked, "We would like to commend both our Investigatorsand their patients for their level of commitment towards the completion ofthis pivotal 8-month study, marking the culmination of critical research in adisease area for which there has not been a novel treatment option in almost15 years. We look forward to assembling and analyzing the data from thisstudy."
ABOUT THE SULONEX (sulodexide oral gelcap) PHASE 3 and PHASE 4 CLINICALPROGRAM
Sulodexide is in a pivotal Phase 3 and Phase 4 clinical program under aSpecial Protocol Assessment with the Food and Drug Administration. Thesetrials are being conducted by the Collaborative Study Group, the world'slargest standing renal clinical trials group.
The clinical plan to support an NDA approval for sulodexide under SubpartH (accelerated approval), as agreed upon with the FDA under an SPA, consistsof: (i) a single Phase 3 trial in subjects with microalbuminuria based on thesurrogate 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 measureclinical 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 isto evaluate the safety and efficacy of sulodexide in subjects with type 2diabetes and persistent microalbuminuria, or diabetic nephropathy, despitebeing treated with a maximum approved or tolerated dose of an angiotensin IIreceptor blocker (ARB) or angiotensin-converting enzyme inhibitor (ACEi). Thestudy is designed for subjects to be on drug for six months, followed by twomonths of evaluation off-drug.
During the drug and off-drug evaluation period, all subjects in the studypopulation are expected to continue to receive maximum approved or tolerateddoses of ACEis or ARBs. Subjects who were not already on maximum approved ortolerated 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 wasdesigned to stabilize blood pressure and to confirm persistentmicroalbuminuria