HAYWARD, Calif., Oct. 20, 2011 /PRNewswire/ -- Metabolex, Inc., a biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, announced today that Dr. Raymond Urbanski has joined the company as Chief Medical Officer. Dr. Urbanski brings extensive clinical development experience to Metabolex, including expertise in all phases of clinical trial design and execution.
Dr. Urbanski was the Vice President and Medical Head of the Established Products Business Unit at Pfizer since 2008 which he built into a global business. From 2004-2008, he held various positions in the Pfizer Global Pharmaceutics Group. He was the Vice President for Research and Development at Suntory Pharmaceutical, Inc. from 2001-2004 and held various positions at Aventis and AstraZeneca between 1998 and 2001. He received his Ph.D. in pharmacology and his M.D. from the University of Medicine and Dentistry of New Jersey.
"Ray is a great addition to our management team," said President and Chief Executive Officer Harold Van Wart, Ph.D. "Ray's leadership roles in well respected pharmaceutical companies, his experience in clinical development and his commercial insights will be critical for us as we advance our lead gout drug candidate arhalofenate into Phase 3 studies and ultimate commercialization. He will also be instrumental in helping the company chart the best course for its other two clinical assets – MBX-2982 and MBX-8025."
Metabolex has initiated three 28-day Phase 2b studies for arhalofenate in gout patients. The first study is a randomized double-blind placebo-controlled study that will evaluate the safety and urate-lowering activity of 400 and 600 mg of arhalofenate used as mono-therapy. Enrollment into this study of 60 patients with hyperuricemia and a diagnosis of gout has been completed.
Metabolex has also initiated Phase 2b studies in which arhalofenate 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 renal insufficiency, while showing excellent renal safety. In addition to lowering glucose, arhalofenate lowered triglycerides and markers of inflammation. Thus, arhalofenate is a potential best-in-class uric acid lowering agent that not only corrects the hyperuricemia associated with gout, but also addresses other aspects of metabolic syndrome such as insulin resistance and hypertriglyceridemia that are prevalent in this patient population.
About Hyperuricemia and Gout
Gout is a chronic, progressive rheumatic disease, caused by an inflammatory response to uric acid crystals deposited in joints and soft tissues as a result of excess uric acid in the blood (hyperuricemia). Elevated serum uric acid levels cause urate crystals for form in joints triggering acute arthritic flares, chronic destructive arthropathy and formation of tophi. According to the NHANES (2007-2008) study, the incidence of hyperuricemia in the US is over 45 million and over 8 million have progressed to a gout diagnosis.
Metabolex is a privately-held biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases. The company has three clinical-stage compounds: arhalofenate, which has completed four Phase 2 trials and is currently conducting three Phase 2b trials for gout; MBX-2982, which has recently completed a Phase 2a trial in patients with Type 2 diabetes; and MBX-8025, which has completed a Phase 2 trial in patients with dyslipidemia.
For additional information about Metabolex and its development pipeline, visit www.metabolex.com.
|SOURCE Metabolex, Inc.|
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