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Zafgen Announces Initiation of Phase 2a Clinical Development with Beloranib in Obesity
Date:11/6/2012

CAMBRIDGE, Mass., Nov. 6, 2012 /PRNewswire/ -- Zafgen, Inc., a leading biopharmaceutical company dedicated to addressing the unmet needs of severely obese patients, today announced that it has initiated Phase 2a clinical testing of  beloranib.  This milestone follows the completion of three consecutive Phase 1b studies demonstrating rapid weight loss, reductions in body fat, improvements in cardiovascular risk factors and encouraging tolerability.

Beloranib, a novel therapy for obesity that utilizes a unique mechanism of action targeting methionine aminopeptidase 2 (MetAP2), is in development to assess its potential to safely and rapidly reduce body weight by restoring balance between the production and utilization of fat.

"This transition to larger and longer clinical trials is a significant milestone for Zafgen and for patients who suffer from severe obesity," Thomas Hughes, Ph.D., president and CEO of Zafgen, said.  "We are looking forward to learning more about the safety and efficacy of treatment with beloranib over a longer period of time.  Given the consistent and rapid weight loss we have observed with beloranib in previous studies, there appears to be significant potential to help severely obese patients, whose options are currently limited, to achieve a healthier weight and improve risk factors associated with type 2 diabetes and cardiovascular disease."

The first Phase 2a clinical trial will evaluate weight loss, safety and pharmacokinetics of beloranib administered twice a week.  Obese men and women with and without type 2 diabetes will receive subcutaneous injections for 12 weeks at eight participating centers.  The trial design is a randomized, double-blind, placebo-controlled study evaluating a range of doses in approximately 150 patients.

"Early results from clinical trials studying beloranib's effects on body weight and cardiovascular risk markers in obese patients have been very encourag
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SOURCE Zafgen, Inc.
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