Zafgen Halts Development Of Beloranib, To Cut Jobs By ~34%
Zacks Investment Research | Jul 19, 2016 09:44PM ET
Zafgen, Inc. (NASDAQ:ZFGN) announced that it has decided to suspend the development of its lead pipeline candidate, beloranib (a MetAP2 inhibitor). We expect investors to react negatively to this disappointing news.
Zafgen was developing beloranib for the treatment of multiple indications, including severe obesity in two rare diseases, Prader-Willi syndrome (PWS) and obesity caused by hypothalamic injury, including craniopharyngioma-associated obesity and severe obesity in the general population.
The company ran into trouble with beloranib when the FDA had placed the candidate’s investigational new drug application on complete clinical hold (Dec 2015) due to an imbalance in severe venous thromboembolic events, including two patient deaths reported in a phase III study (bestPWS ZAF-311). The study evaluated beloranib in patients with PWS. Though the company reported positive efficacy results from the study earlier this year, the path forward for the candidate was uncertain.
Lately, Zafgen held a type A meeting with the FDA to discuss clinical and pre-clinical data on beloranib as well as a proposed risk mitigation strategy for beloranib in PWS. Based on discussions with the regulatory authority and review of other considerations, Zafgen realized that the obstacles, costs and development timelines to gain marketing approval for beloranib are way too much to explain additional investment in the program.
Instead, the company intends to focus its resources on the development of a differentiated second-generation MetAP2 inhibitor, ZGN-1061, as a potential new treatment for prevalent obesity-related indications. The company noted that the candidate possesses a promising safety profile with reduced potential to impact thrombosis, unlike beloranib.
Currently, Zafgen is screening patients to initiate a phase I study for the evaluation of safety, tolerability, and weight loss efficacy of ZGN-1061 over a treatment period of four weeks. Data from the study is anticipated by the end of the first quarter of 2017. The company plans to move ZGN-1061 into a late-stage development for the treatment of severe and complicated obesity, if things go well.
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