Zafgen pulls IND application for Prader-Willi Syndrome candidate; CMO resigns
Zafgen (NASDAQ:ZFGN) has suspended plans to file an IND for its Prader-Willi Syndrome candidate after recently observing muscle degeneration and other anomalies in rodent toxicology studies. The effects were observed in both the treatment and controlarms.
Zafgen concurrently announced the resignation of its CMO, Dr. Dennis Kim, as well as the appointment of Dr. Priya Singhal, as head of R&D.
Earlier this year, Zafgen announced positive data for its lead program in Type 2 diabetes, where the second cohort of its Phase 2 clinical trial met all of its primary objectives, including a statistically significant reduction in A1C. Zafgenis preparing for a Type A meeting with the FDA to address the regulator’s clinical hold on the program related to concerns of cardiovascular safety risk.