Shares of Zafgen Inc (NASDAQ: ZFGN) soared about 20 percent in Thursday's pre-market trading after its obesity drug beloranib achieved its primary endpoint in a mid-stage trial.
The biopharma company said that beloranib, a MetAP2 inhibitor, in the treatment of severe obesity complicated by type 2 diabetes, showed statistically and clinically significant improvements in body weight and glycemic control over six months of randomized treatment.
The clinical trial achieved its primary efficacy 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.
In January, Zafgen announced that Phase 3 clinical trial of beloranib in Prader-Willi syndrome (PWS) had achieved its co-primary endpoints, demonstrating statistically significant and clinically meaningful weight loss and improvement in hyperphagia-related behaviors at both the 2.4 mg and 1.8 mg dose levels.
Zafgen plans to present data from both the studies to the FDA along with a proposal for a risk mitigation strategy for beloranib in PWS in an effort to resolve the complete clinical hold the FDA placed on the beloranib IND (investigational new drug) in December 2015.
Shares of Zafgen were last up $0.86, or 11.56 percent, at $8.30. The stock has gained 18 percent this year.
See more from Benzinga
- 2 Catalysts Coming For Etsy Investors
- Sterne Agee Cuts Peabody Energy, Sees Bowie Transaction Risks
- Do Cheesecake Factory Sales Predict...Nordstrom's Numbers?
© 2016 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.