Zafgen Initiates Phase 3 Trial Of Beloranib In Prader-Willi Syndrome

(RTTNews) - Zafgen, Inc. (ZFGN) announced that it has initiated the first Phase 3 clinical trial, in the United States, with its lead product candidate, beloranib, in the treatment of Prader-Willi syndrome or PWS.

According to the company, PWS is a rare disease and the most common known genetic cause of life-threatening obesity. It is a complex metabolic syndrome characterized by hyperphagia and obesity resulting from impaired functioning of the hypothalamus.

Zafgen said the "bestPWS" trial or Beloranib Efficacy Safety and Tolerability in PWS, is a randomized, double-blind, placebo-controlled trial in obese adolescents and adults with Prader-Willi syndrome to evaluate food-related behaviors, total body fat mass, and safety of beloranib.

The two primary efficacy endpoints are planned to be changes in hyperphagia-related behaviors and/or total body fat mass from baseline to the end of randomized treatment. Key secondary endpoints include changes in lipid parameters and body weight, the company stated.

Zafgen also said it has been granted orphan drug status in both the United States and the European Union for beloranib for the treatment of PWS.