Boston biotech announces death of second patient participating in clinical trial
Boston biotech Zafgen announced Wednesday a second patient participating in the clinical trial of an obesity-fighting drug beloranib has died. The company said the patient’s death was caused by a blood clotting in the lungs.
“Our thoughts are with the patient and their family at this time,’’ Dr. Thomas Hughes, CEO of Zafgen, said in a statement. “Patient safety remains our top priority and we are investigating the circumstances around this event.’’
Hughes said the company is discussing next steps of the beloranib program with the Food and Drug Administration.
As when the first patient’s death was announced in October, the company did not say the drug, which is meant to treat Prader-Willi syndrome, caused the patient’s death. But both patients were taking the drug, not a placebo, according to The Boston Globe.
Biotech analyst Joseph Schwartz, who is managing director at the Leerink Partners, told the Globe Zafgen likely won’t get regulatory approval until another clinical trial is conducted.
“You don’t know if it’s absolutely related to the drug but it doesn’t look good,’’ he said. “Now you have two events, so it increases the risk. Although there is a great unmet medical need, the FDA is always concerned about safety foremost.’’
Shares in the company plunged 59.8 percent on Wednesday afternoon.
Read the full Globe report here.
To comment, please create a screen name in your profile
To comment, please verify your email address
Conversation
This discussion has ended. Please join elsewhere on Boston.com