Zafgen, Inc. ZFGN announced positive efficacy results from a phase IIb (ZAF-203) study on its lead pipeline candidate, beloranib (a MetAP2 inhibitor). The study is evaluating beloranib for the treatment of patients with severe obesity complicated by type II diabetes. The company’s shares were up 2.2% following the announcement.
In the study, beloranib showed statistically and clinically significant improvements in body weight and glycemic control over a period of six months of randomized treatment.
Results from the study revealed that patients on 1.8 mg and 1.2 mg doses of beloranib witnessed 12.7% and 13.5% fall in body weight, respectively, compared to a 3.1% reduction in the placebo arm, thereby meeting the primary efficacy endpoint of the study. In addition, patients in each dose arm achieved on average an absolute reduction in HbA1c of 2% compared to a reduction of 0.6% for placebo.
Zafgen said in its press release that in the study there were a total of nine serious adverse events (SAEs) in eight patients. While one of the SAEs (as previously disclosed by the company) was pulmonary embolism in the 1.2 mg treatment group, two additional venous thromboembolic events were identified in patients in this study – deep vein thrombosis in a patient who had received 1.8 mg of beloranib, and superficial thrombophlebitis in a patient who had received 1.2 mg of beloranib.
We note that Zafgen’s shares have been on an upswing since the time (Jan 2016) it reported positive efficacy data from a pivotal phase III bestPWS ZAF-311 study on beloranib in patients suffering from Prader-Willi syndrome (PWS).
Zafgen plans to present to the FDA the data from the ZAF-311 and ZAF-203 studies. Apart from this, the company is looking to discuss a risk mitigation strategy for beloranib in PWS with the FDA. The company intends to resolve the complete clinical hold, which the regulatory agency had placed on beloranib’s investigational new drug application in Dec 2015 due to an imbalance in severe venous thromboembolic events, including two patient deaths.
We expect investor focus to remain on updates pertaining to the development of beloranib.
Zafgen is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Horizon Pharma plc HZNP, Anika Therapeutics Inc. ANIK and Actelion Ltd. ALIOF. All three carry a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
ACTELION LTD (ALIOF): Free Stock Analysis Report
ANIKA THERAPEUT (ANIK): Free Stock Analysis Report
ZAFGEN INC (ZFGN): Free Stock Analysis Report
HORIZON PHARMA (HZNP): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research