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Zafgen Announces Partial Clinical Hold Affecting Beloranib Trials

The following excerpt is from the company's SEC filing.

th, at 8:30 a.m. E.T.

BOSTON Oct. 16, 2015 Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that it received verbal notice late yesterday from the U.S. Food and Drug Administration (FDA) that beloranib has been placed on partial clinical hold. This partial clinical hold impacts ongoing or planned clinical trials, including ZAF-311 and ZAF-312. A partial clinical hold is an order that the FDA issues to delay or suspend part of a sponsors clinical work requested under its investigational new drug (IND) application.

As previously reported, Zafgen learned of a death in the ongoing Phase 3 bestPWS study (ZAF-311) of beloranib in Prader-Willi Syndrome (PWS). While the cause of death remains unknown, the patients treatment assignment has been unblinded and it is now known that the patient was receiving beloranib. Due to previously reported thromboembolic events in ongoing and prior clinical trials of beloranib and the unknown nature of the death, the FDA gave verbal notice of a partial clinical hold to institute measures to ensure patient safety. Patients currently participating in the ZAF-311 study will be screened for existing thrombotic disease prior to receiving further study drug and regularly monitored through the completion of the study. Given that the study is near complete, at this time, the Company expects to report top-line results in the first quarter of 2016. Similar screening and monitoring is being considered for the ongoing Phase 2b study (ZAF-203) in patients with severe obesity complicated by type 2 diabetes. The Company now anticipates that the PWS Phase 3 clinical trial, ZAF-312, will be initiated after ZAF-311 is completed and a full assessment of the safety and efficacy of beloranib is performed by the FDA.

Patient safety is our top priority, and we will work closely with the FDA to implement these measures to support the further development of beloranib, said Dr. Thomas Hughes, Chief Executive Officer of Zafgen.

Conference Call Information

Zafgen will host an investor conference call today, October 16, 2015 at 8:30 a.m., Eastern Time, to discuss todays announcement. Investors and other interested parties may participate by dialing (844) 824-7428 in the United States or (973) 500-2177 outside the United States and referencing conference ID number 63172382. The call will also be webcast live on the Companys website at You can access the replay for seven days by dialing (855) 859-2056 in the United States or (404) 537-3406 outside the United States and referencing conference ID number 63172382.

About Beloranib

Beloranib is a novel, first-in-class injectable small molecule therapy with a unique mechanism of action that reduces hunger while stimulating...