Zafgen endocrine/metabolic news
Zafgen will reduce headcount by 47 (34%) to 31 and discontinue development of beloranib ( ZGN-440) to focus on developing ZGN-1061 to treat severe and complicated obesity. The cuts include President Patrick Loustau and Chief Commercial Officer Alicia Secor. Beloranib is a prototype methionine aminopeptidase 2 (MetAP2) inhibitor, and ZGN-1061 is a second-generation MetAP2 inhibitor.
In December, FDA placed beloranib under a clinical hold after Zafgen reported two patient deaths in a Phase III trial to treat Prader-Willi syndrome. The company later said beloranib met the primary endpoints of that study and a Phase IIb trial to treat severe obesity complicated by Type II diabetes. In February, Zafgen said there were 11 cases of thrombotic events among more than 500 patients. On a conference call to discuss the restructuring, Zafgen said FDA wanted the company to conduct a longer Phase III trial than it had proposed and that Zafgen could not justify continued investment in the program. Because the company will not pursue a lift of the clinical hold, it cannot make beloranib available to Prader-Willi patients under a compassionate use program (see BioCentury, Dec. 7, 2015; Jan. 25, 2016 & Feb. 22, 2016). ...