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Zafgen Announces Initial Results from Phase 2a Study of Beloranib in Patients with Prader-Willi Syndrome
Date:1/15/2014

ences.  Key hormones, including adiponectin and leptin, also showed changes characteristic of non-PWS obese patients, demonstrating that the drug was highly active in these patients and had a similar effect to that seen in non-PWS patients.

"These results are very exciting for the treatment of PWS, as most patients showed improvements in body weight, hunger-related behaviors, and body fat content, despite the increased food intake included in the trial design," explained Dr. Jennifer Miller, Associate Professor of Pediatric Endocrinology, University of Florida, and Principal Investigator for the study.  "PWS is a complex genetic disease that is difficult to treat and the results of this trial demonstrate that beloranib has a beneficial impact on this underserved patient population.  Notably, we were encouraged by reports of fullness, a first-time occurrence for PWS patients who otherwise lack the capacity to feel sated after meals."

"PWS patients remain severely impacted by their disease and are not treatable with other anti-obesity agents," added Janalee Heinemann, Director of Research & Medical Affairs for the Prader-Willi Syndrome Association (USA).  "PWS represents one of the most severe forms of genetic obesity and we welcome these results, which are a significant step towards finding a treatment for those suffering from this life threatening condition."

Beloranib, a novel obesity therapy that utilizes a unique mechanism of action, is being studied for its ability to reduce body weight and improve cardiometabolic risk factors in obese patients with and without PWS.  This study was a randomized, double-blind, placebo-controlled trial to evaluate the safety and tolerability of a dose range of beloranib administered as twice-weekly subcutaneous injections for four weeks.  The randomized treatment part of the study was follow
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SOURCE Zafgen, Inc.
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