Forced to at least temporarily delay the clinical development of its obesity drug beloranib as it explores the reasons why a patient in a late-stage study died, Zafgen ($ZFGN) has decided to simply wrap up the randomized portion of two studies early and analyze the data it has now.
Zafgen has been stumbling badly through a terrible stretch that has claimed over half the value of its stock during the past week. The biotech maintained an awkward, stony silence as rumors about trouble in the pipeline spread after execs at the biotech suddenly canceled a planned roadshow with investors. Only days after its stock plunged did the company finally admit that a patient taking beloranib had died, leaving Zafgen under a cloud of suspicion on a safety issue, which can be particularly troublesome for an obesity drug.
While Zafgen still doesn't know what caused the patient's death, the study has begun screening patients for thrombotic disease, as that is a known safety issue with this drug. Analysts have been concerned that any significant safety issues with beloranib would, at best, severely restrict its use.
The FDA responded to the death by placing the study on partial hold, delaying Zafgen's work on the drug for Prader Willi syndrome, a rare binge eating disorder. But the biotech says today that regulators have agreed to review the data from the Phase III study, which had been nearing completion when the trouble hit. Zafgen is also wrapping up its ZAF-203 Phase IIb clinical trial of beloranib in patients with severe obesity complicated by Type 2 diabetes.
Zafgen's battered stock was up 6% this morning in response to the trial update.
"The strategic decision to analyze results from the ZAF-311 and ZAF-203 clinical trials early allows us to better preserve data integrity by limiting dose interruption in both clinical trials, and inform the future development of this important product candidate," said Dennis Kim, the CMO of Zafgen. "PWS is a life-threatening and complex rare disorder that severely impacts the quality of life of both patients and their families, and we continue to believe that beloranib may have an important role in addressing hyperphagia and underlying obesity associated with this disorder. We will continue to treat, closely monitor and follow patients in the ZAF-311 extension portion of the clinical trial."
- here's the release