ZAFGEN Reports Encouraging Results From Phase 2 trial of Beloranib in Patients with Obesity-Related Hypothalamic Injury

ZAFGEN Reports Encouraging Results From Phase 2 trial of Beloranib in Patients with Obesity-Related Hypothalamic Injury

shutterstock_178890782Zafgen biopharmaceuticals, a company that develops treatments for patients with obesity and metabolic disorders, recently announced in a press release, results of a randomized, double-blind, phase 2 placebo controlled trial called ZAF-221, that aims to determine the efficacy of belaranib in patients with obesity.

Beloranib is a MetAP2 inhibitor, an enzyme that modulates the activity of key cellular processes that control metabolism, thus reducing hunger while stimulating the use of stored fat as an energy source. Zafgen holds the total rights for Beloranib, licensed from Chong Kun Dang (CKD) Pharmaceutical Corp. of South Korea.

In the ZAF-221 trial, 14 patients with hypothalamic injury associated obesity, or HIAO (confirmed by magnetic resonance imaging (MRI) were randomized to receive twice-weekly subcutaneous injections of 1.8 mg beloranib or placebo. The study’s primary endpoints were to evaluate weight reduction and safety for four weeks, followed by an optional four-week open-label extension.

Results from the treatment with Beloranib showed a mean weight loss of 3.4 kg and 6.2 kg in patients with HIAO after four and eight weeks of treatment, respectively, in contrast to 0.3 kg mean weight loss in patients treated with placebo for four weeks (p = 0.01). Furthermore, Bleloranib was able to improve cardiovascular disease risk factors of lipids and inflammation. The drug was well tolerated, with no major adverse effects.

In the press release Dennis Kim, M.D., Chief Medical Officer of Zafgen said, “We are extremely pleased with these results, which differentiate beloranib from other weight loss agents. Beloranib’s impact to restore balance to production and utilization of fat is further validated with these findings. With these results in hand, we plan to pursue HIAO as an extension of our work in Prader-Willi syndrome, or PWS. We believe beloranib shows tremendous potential to improve the lives of those impacted by HIAO and PWS, and for whom there are limited effective pharmaceutical alternatives. In 2015, we aim to establish the regulatory path for a registration program with U.S. and EU regulatory authorities.”

“We are delighted by these clinical results that provide additional evidence for our hypothesis about beloranib’s mechanism and establish the drug’s unique extra-hypothalamic mode of action. Along with PWS and severe obesity in the general population, HIAO is the third indication for which we have established proof of concept for beloranib,” said Thomas Hughes, Ph.D., Chief Executive Officer of Zafgen, in the press release. “We are enthusiastic to continue development of beloranib for the treatment of patients with severe and complex forms of obesity.”

Professor Joseph Proietto, Head of Weight Control Clinic, Austin Health, Melbourne, Australia said, “These data represent a significant step forward in understanding the role of MetAP2 inhibition as a useful therapeutic approach to treating complex forms of obesity characterized by hypothalamic dysfunction,”. “These results are innovative, as they represent an exceptional level of success in the pharmaceutical treatment of HIAO, and are very encouraging for our field, as well as for these patients who remain largely beyond the reach of currently marketed pharmaceutical agents.”

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