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news.The US Food and Drug Administration (FDA) has placed Zafgen's beloranib investigational new drug (IND) application on complete hold following the death of a second patient during the clinical trial.
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The move affects the ongoing open label extension (OLE) part of the pivotal Phase 3 ZAF-311 bestPWS trial in patients with Prader-Willi syndrome (PWS).
A complete clinical hold requires a sponsor to stop all clinical work requested under the company’s IND application.
Zafgen said it continues to expect top-line results of the randomized part of the trial in the first quarter of 2016.
Zafgen CEO Thomas Hughes said: "We are working diligently to assemble and analyze the data from our ZAF-311 clinical trial to be able to provide a clear view of the safety and efficacy of beloranib in the PWS population.
"We remain committed to advancing beloranib as a potential new therapy for this underserved patient population."
Beloranib is being studied as a first-in-class obesity therapy that demonstrates a mechanism of action through methionine aminopeptidase 2 (MetAP2 ) inhibition.
MetAP2 inhibitors re-establish balance to the ways the body packages and metabolizes fat.
Inhibitors of MetAP2 reduce the production of new fatty acid molecules by the liver and help to convert stored fats into useful energy.
Zafgen holds global rights (exclusive of Korea) to develop and commercialize beloranib. The company licensed the drug from CKD Pharma.