Zafgen’s Beloranib Meets Primary Endpoint in Phase 2b Trial

Zafgen has disclosed positive efficacy results from its Phase 2b clinical trial assessing beloranib for the treatment of severe obesity complicated by Type 2 diabetes.

The clinical trial reached its primary efficacy endpoint, as treatment with the 1.8- and 1.2-mg doses of beloranib resulted in 12.7 percent and 13.5 percent reductions in body weight, respectively, compared with a reduction of 3.1 percent for placebo.

The news comes after the deaths of two patients in a Phase 3 study of the candidate in Prader-Willi syndrome. Following the deaths, the FDA placed a complete clinical hold on the randomized portion of the trial, while the company continued the open-label extension portion of the trial.