Sage Therapeutics announces results from Sage-547 trial did not meet endpoint

Sage Therapeutics (SAGE) reported top-line results from its Phase 3 STATUS Trial of brexanolone, or SAGE-547, in the treatment super-refractory status epilepticus, or SRSE.

The trial was testing Sage’s drug, brexanolone, plus standard of care in patients with super-refractory status epilepticus (SRSE) whose seizures persisted despite earlier treatments, versus a placebo plus standard of care.

The study did not meet the primary endpoint, comparing success in weaning of third-line agents and resolution of potentially life-threatening status epilepticus with brexanolone vs. placebo when added to standard-of-care.

The company is also testing the same drug in post-partum depression, with results of a two late-stage trials in such patients expected before the end of the year. But Tuesday’s failure is raising some doubts about whether that trial will succeed.

There are no treatments for SRSE currently approved by the FDA.

PRICE ACTION:

SAGE closed at $88.52. It last traded at $66.09.

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