Sage Therapeutics (NASDAQ: SAGE) shares are down about 15% after the a clinical-stage biopharmaceutical company announced the results from the Phase 3 STATUS Trial of did not meet the primary endpoint. The trial of brexanolone (SAGE-547) in the treatment super-refractory status epilepticus (SRSE).
SRSE is a life-threatening persistent state of seizure that does not respond to first-, second- or third-line treatments, is a neurological emergency that may cause death or life-altering outcomes. There are no treatments for SRSE currently approved by the U.S. Food and Drug Administration (FDA).
Sage Therapeutics explained that demographics and baseline characteristics were well-balanced between treatment groups in the study.
Jeff Jonas, M.D., Chief Executive Officer of Sage, said in a statement, “Although we did not meet the primary endpoint, this first-ever trial in a highly variable and complex patient population confirms that research in a critical care unit is possible and deepens our understanding of GABA mechanisms and their effect on brain circuitry. As we continue examining data from the STATUS Trial in the coming weeks, I'm hopeful this information will inform current treatments, and aid in the development of future treatments for patients with SRSE."
"SRSE is an extremely complicated condition to treat and there is a significant unmet need for new treatments," said Eric Rosenthal, M.D., co-Principal Investigator of the STATUS Trial, Associate Director of the Neurosciences Intensive Care Unit and faculty member of the Epilepsy Service at Massachusetts General Hospital. "We have learned a great deal from the STATUS Trial and while I share the disappointment of patients and their families who participated in the trial, the STATUS Trial represents a significant contribution to SRSE research and I hope these data will provide a foundation for development of future treatments for patients with this devastating condition."