Officials with FDA Halt US Trials for Diabetes Drug

Officials with Zafgen, Inc. this morning announced that the company received a letter last week from the FDA placing a clinical hold on the Investigational New Drug Application (IND) for its first US clinical trial of ZGN-1061, an investigational MetAP2 inhibitor currently in development for the treatment of type 2 diabetes.

FDA officials cited the possibility of a cardiovascular (CV) safety risk based on Zafgen's prior compound and outlined 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.

Zafgen officials noted in a press release that they continue to advance their ongoing ex-US phase 2 clinical trial of ZGN-1061, which includes a 1.8 mg dose cohort. Dosing in this clinical trial was recently completed and, while still blinded, no CV safety signals have been observed to date, and data on this cohort is expected in the early portion of 2019.

Previously reported full 12-week results for the initial cohort of this phase 2 proof-of-concept clinical trial, which included a range of doses up to 0.9 mg indicated that the medication met all primary endpoints, demonstrating proof-of-concept efficacy with robust A1C lowering effects, and a favorable safety and tolerability profile generally comparable to placebo, with no treatment-related serious adverse events and no CV safety signals observed.