Controversial Obesity Drug Succeeds in Trial
Tests were halted in December on beloranib, Zafgen's drug to treat obesity, after two patients died.
But the company announced that before that stoppage, patients given 1.8 mg and 1.2 mg doses of beloranib lost 12.7 and 13.5 percent of their body weight, respectively, in a mid-stage study. Patients given a placebo lost just 3.1 percent of their weight.
The FDA requested that Zafgen halt all tests on beloranib after a second patient died during a trial. Obesity treatments have generally been plagued by safety concerns, particularly related to heart risk and birth defects, and several have been taken off the market for these reasons.
Last month, Zafgen said beloranib was successful in treating Prader-Willi syndrome (PWS), the most common genetic cause of life-threatening obesity. The company plans to present the FDA with data from both trials, conducted before the FDA stopped tests, and a proposal for a risk mitigation strategy for beloranib in PWS to resolve the complete clinical hold.
Researchers are working to better understand the potential impact of the drug on thrombosis. Both patient deaths associated with the treatment were related to blood clotting.