FDA puts Zafgen's obesity drug trial on partial hold

Send a link to a friend  Share

[October 16, 2015]   (Reuters) - Zafgen Inc said the U.S. Food and Drug Administration had put a late-stage trial of its obesity drug on partial hold, two days after the drug developer reported the death of a patient during the study.

Zafgen's stock was down about 24 percent at $15.92 in light premarket trading.

Zafgen said it still expects to report results from the study on the drug, Beloranib, in the first quarter of 2016 as the trial is nearly complete.

A partial clinical hold is an order the FDA issues to delay or suspend part of a company's clinical study.

The company said the partial hold is expected to impact both ongoing and planned trials on the drug.

On Wednesday, Zafgen said a patient died during the late-stage trial testing the company's drug to treat Prader-Willi syndrome, a rare genetic disorder that leads to obesity.

The trial involved 108 patients, with a third of them given the drug and as many given a placebo. The rest of the patients were randomly given either the drug or a placebo.

(Reporting by Amrutha Penumudi in Bengaluru; Editing by Don Sebastian)

[© 2015 Thomson Reuters. All rights reserved.]

Copyright 2015 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

 

 

Back to top