Thursday, January 21, 2016

Zafgen’s Halted Obesity Treatment Shows Effectiveness

Zafgen Inc. shares more than doubled Wednesday after the biopharmaceutical company said its treatment for a rare obesity disorder showed effectiveness in reducing body weight in a late-stage trial that also included two previously announced deaths.

The results gave hope to investors that the Boston-based company might be able to convince the Food and Drug Administration to remove the agency’s clinical hold on the treatment, which received the designation following news of the first patient’s death in October.

Zafgen’s beloranib treats Prader-Willi syndrome, a genetic disorder that results in life-threatening obesity because of unrelenting hunger. There is no cure for the disease, which affects one in 12,000 to 15,000 people, according to the Prader-Willi Syndrome Association.

The company said Wednesday that beloranib demonstrated a significant reduction in both body weight and behaviors related to hyperphagia, or abnormally increased appetite, the first investigational drug to do so.

“These pathologies are the two hallmarks of the disease,” Chief Executive Thomas Hughes said. “They’re widely agreed upon as the most important and completely unmet needs.”

Specifically, Zafgen said beloranib reduced body weight, relative to the placebo, by 9.45% at the higher dose and 8.2% at the lower dose. The treatment also showed a statistically significant decrease in hunger-associated behaviors based on the questionnaire used to study hyperphagia.

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