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Metabolex Appoints Raymond Urbanski M.D., Ph.D. to Position of Chief Medical Officer
Date:10/20/2011

e is being combined with the xanthine oxidase inhibitors allopurinol and febuxostat (Uloric™, Takeda Pharmaceutical Company Limited). The study using arhalofenate (400 and 600 mg) in combination with allopurinol is a randomized double-blind placebo-controlled study in patients who are refractory to allopurinol (do not reach their serum uric acid goal of <6 mg/dL). The primary endpoint is the percentage of patients that reach goal.  

The Phase 2b combination study with febuxostat is an open-label study in which 400 and 600 mg doses of arhalofenate are added on to febuxostat (80 mg) to assess how low uric acid levels can be driven.  This study is also fully enrolled. Data from all three Phase 2b studies will be available in the second quarter of 2012.  

"I am very excited about joining Metabolex and leading the arhalofenate gout program," said Ray Urbanski. "The Phase 2 program that is in place reflects the potential that arhalofenate has of achieving a broad label for the treatment of hyperuricemia and gout including first-line use and, for patients not reaching treatment goals, in combination with allopurinol or febuxostat, as well as addressing some common gout co-morbidities. Arhalofenate is a potential best-in-class drug that is highly de-risked and has tremendous commercial potential."  

Arhalofenate has previously completed eight Phase 1 and four Phase 2 studies in patients with Type 2 diabetes which demonstrate that it has excellent safety and tolerability in more than 550 patients for up to 6 months of treatment. The drug has completed all preclinical safety studies including the carcinogenicity studies and is therefore highly de-risked with regard to both preclinical and clinical safety.  

The clinical data from the diabetes trials showed that arhalofenate exhibited robust, dose-dependent reductions in serum uric acid.  These reductions were fully retained in patients with mild to moderate re
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SOURCE Metabolex, Inc.
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