Another blow for Zafgen, as FDA issues clinical hold on asthma drug

Boston, USA-based biotech firm Zafgen (Nasdaq: ZFGN) saw its share plummet 42.31% to $5.25 after it said yesterday that it received a letter last week from the US Food and Drug Administration placing a clinical hold on the Investigational New Drug Application (IND) for its first US clinical trial of ZGN-1061, the company’s second-generation, investigational MetAP2 inhibitor currently in development for the treatment of type 2 diabetes.

The FDA cited the possibility of cardiovascular (CV) safety risk based on the company’s prior compound and outlined multiple potential paths for moving forward, including nonclinical or clinical options, to address these concerns in the ongoing development of ZGN-1061. The company plans to assess these options and request a Type A meeting with the agency to discuss next steps with the program.

The news comes two years after Zafgen abandoned its lead compound beloranib in Prader-Willi syndrome (PWS) following a spectacular failure in late-stage testing that cost lives.