WASHINGTON, Dec. 2 (UPI) — A second patient has died in a clinical trial for the drug beloranib, which is being tested for use with a rare obesity disorder called Prader-Willi syndrome.
Beloranib reduces hunger while stimulating the body to use stored fat for energy, which doctors hope will be effective for patients who have Prader-Willi, a genetic condition that includes developing an insatiable appetite, chronic eating and obesity.
The trial was briefly paused in October after the first death of a participant. The drug’s manufacturer, Zafgen Inc., reported Wednesday a second patient died during the Phase III trial after being diagnosed with blood blockages in the lungs.
Zafgen opted to continue clinical data analysis from two stages of trials for the drug, as well as continue the ongoing Phase III trial, which allows patients who completed the main trial to continue taking the drug for an extended period of time.
“Our thoughts are with the patient and their family at this time,” said Dr. Thomas Hughes, chief executive officer of Zafgen, in a press release. “Patient safety remains our top priority and we are investigating the circumstances around this event. We are also engaging in discussions with the FDA while we determine the next steps with the beloranib program.”
In October, upon reporting the first study participant’s death, the company said in a press release the cause of death had been respiratory failure due to pulmonary emboli, the same diagnosis given to the second participant. The company said at the time, however, that it was unsure if the blockages were due to treatment with the experimental drug.
The company said it sought to continue testing the drug after the first death because of the promise it has shown in trials. Before allowing Zafgen to continue the clinical trial, the FDA assessed patients enrolled in the study for high risk of clotting, which already was a concern of the agency.
Hughes told the Boston Globe in October the company had “no basis to suggest that taking beloranib triggers clots,” saying that blood clotting is a health concern with Prader-Willi patients already.
A lawsuit was filed in October claiming Zafgen had withheld information about adverse events experienced by patients in the trial, as well as alleging the first death in the trial was of a patient who was being treated with the drug, rather than a placebo.
News of the death slashed Zafgen’s stock price in half before the market opened Wednesday.
