E Zafgen Soars 78% On Positive Phase 3 Obesity Results

Yesterday, shares of Zafgen, Inc. (ZFGN) closed up 78% after the company had announced positive phase 3 results in patients with obesity. More specifically, the company’s drug beloranib, is being used to treat patients with a disorder known as Prader-Willi Syndrome — PWS. The study shows that no matter how much patients eat they never seem to curb their appetite. They are hungry all the time, and because of that gain an excessive amount of weight. 

The phase 3 trial is known as the best PWS ZAF-311 study, and it recruited 81 patients who were evaluated for safety and efficacy on the belornib drug.

The data released yesterday is from 74 patients who went through the entire trial, but it also included 27 patients who only finished 75% of their treatment. The FDA has placed a clinical hold on the beloranib drug back in October of 2015. The trial lasted for a six-month period and patients were followed to determine if they were able to lose more weight taking beloranib than the placebo. The company stated that it had met both co-primary efficacy endpoints in the trial. The drug was able to reduce a patients weight and a reduction in hyperphagia relater behaviors. Hyperphagia is an injury to the hypthalamus — brain that controls hormone production. It is responsible for generating several hormones that regulate:

About the weight reduction, patients saw a decrease in weight in both dose levels. The 2.4 mg drug reduced patients weight by 9.45%, and the 1.8 mg drug reduced patients weight by 8.2%. Both reductions in weight with beloranib were statistically significant compared to placebo. Zafgen stated that it will submit this safety and efficacy data, along with data from another trial to show the FDA that the drug is safe. Now the company must await further response from the FDA to determine the next course of action with the beloranib program.