FDA puts Zafgen's obesity drug trials on partial hold
{{#rendered}} {{/rendered}}
Zafgen Inc said the U.S. Food and Drug Administration has put a partial hold on the development of its obesity drug, two days after the drug developer reported the death of a patient during a late-stage study.
Zafgen's stock was down about 33.4 percent at $14.00 in premarket trading.
The company, which focuses on drugs for metabolic disorders, said the partial hold will affect all ongoing and planned trials involving its lead drug, beloranib.
{{#rendered}} {{/rendered}}
However, Zafgen said it still expects to report results from the late-stage study in the first quarter of 2016 as the trial is nearly complete.
A second late-stage study planned on the drug will start only after the results from the first study are assessed by the FDA, the company said.
- Weight-loss surgery may not increase health costs for diabetes
- For mildly obese diabetics, weight loss surgery may be helpful
- Americans spend the most on health care, but have the lowest life expectancies
- Mothers may be unwilling to believe their children are obese
- 4 times it’s healthier to be overweight
A partial clinical hold is an order the FDA issues to delay or suspend part of a company's clinical study.
{{#rendered}} {{/rendered}}
Zafgen said on Wednesday the patient died during the late-stage trial testing the drug to treat Prader-Willi syndrome, a rare genetic disorder that leads to obesity.
Analysts have said the patient could have been administered a placebo rather than the drug.
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.
{{#rendered}} {{/rendered}}
The beloranib trials started in October last year and the drug had passed all safety tests conducted by experts, analysts said.
Prader-Willi syndrome is the most common genetic cause of life-threatening obesity. People with the disorder have an unrelenting hunger that drives them to overeat, which leads to excessive weight gain.