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

CAMBRIDGE, Mass., Jan. 15, 2014 /PRNewswire/ -- Zafgen, Inc., a leading biopharmaceutical company dedicated to addressing the unmet needs of severely obese patients, today announced initial results from its Phase 2a study of beloranib, a selective inhibitor of methionine aminopeptidase 2 (MetAP2), in patients with Prader-Willi syndrome (PWS), a severe form of genetic obesity.  These results showed improvements in body weight, hunger-related behaviors, and body composition, including reductions in body fat content and preserved lean body mass following four weeks of treatment. 

These changes were observed despite the increased caloric intake that was a component of this trial.  Known markers of beloranib response including those associated with cardiovascular disease risk were also improved, demonstrating that PWS patients responded to the molecular mechanism of beloranib.

"The results of this short-term proof-of-concept study are very promising and underscore our belief that beloranib has the potential to successfully treat this severe form of obesity.  To our knowledge, this study represents the largest placebo-controlled, randomized, multiple dose trial to date for obesity in this patient population, and these results bode well for further study of beloranib in patients with this devastating condition," said Thomas Hughes, Ph.D., President and Chief Executive Officer of Zafgen.

Similar to results seen in non-PWS obese patient populations, beloranib treatment in this study reduced body fat content by 8.1% vs. placebo in four weeks of treatment at the highest study dose of 1.8 mg, despite a 50% increased daily caloric allowance.  Hunger-related behaviors improved, and a trend towards overall improvement in body weight was seen, although this did not reach statistical significance, in part due to the fact that study was not powered to demonstrate these differ
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SOURCE Zafgen, Inc.
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