Zafgen’s Beloranib Meets Primary Endpoint
An obesity candidate linked to patient deaths during a clinical trial last year may have a potential path forward after its sponsor revealed that it met its co-primary endpoints in a Phase 3 study.
Zafgen’s beloranib demonstrated a statistically significant reduction in both body weight and behaviors related to hyperphagia.
Following the deaths of two patients in the trial last December, the FDA placed a complete clinical hold on the randomized portion of the trial, while the company continued the open-label extension portion of the study.
Zafgen’s newly released data comes from the randomized portion of the study that was stopped, as the company thought it had sufficient efficacy data, spokeswoman Susan Francis said.
While the full clinical hold remains in effect, Zafgen says it plans to present safety and efficacy data to the FDA from earlier studies, as well as propose a risk mitigation strategy for the candidate.
Spokeswoman Michelle Strier said the company plans to discuss with the agency whether an additional Phase 3 trial is needed before submitting beloranib for approval.