Zafgen’s controversial obesity drug beloranib has been shown to reduce body weight in type 2 diabetic patients in a Phase 2b trial.
The clinical trial achieved its primary endpoint, as treatment with the 1.8 mg and the 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 results come from trials conducted before the FDA forced a halt to all studies after a second participant died from an artery blockage when testing the drug in the genetic disorder Prader-Willi syndrome (PWS).
Nevertheless, last month the company announced that a Phase III trial in PWS had achieved its co-primary endpoints, demonstrating statistically significant weight loss and improvement in hyperphagia-related behaviors at both the 2.4 mg and 1.8 mg dose levels.
Zafgen says that it plans to present both of these results to the FDA along with a proposal for a risk mitigation strategy for beloranib in PWS in an effort to resolve the block on trials.
Dr. Thomas Hughes, Zafgen’s CEO, added: "We are actively working to better understand the mechanisms and incidence of underlying thromboembolic disease in PWS and severe obesity, as well as the potential impact of beloranib treatment on thrombosis in order to develop a strategy for risk mitigation."
Beloranib is a novel, first-in-class injectable small molecule therapy with a unique mechanism of action that reduces hunger while stimulating the use of stored fat as an energy source. The drug is a potent inhibitor of MetAP2, an enzyme that modulates the activity of key cellular processes that control metabolism.