Sage falls on Phase III data for seizure indication

Sage Therapeutics Inc. (NASDAQ:SAGE) lost $12.12 (14%) to $76.40 on Tuesday after it said brexanolone (SAGE-547) missed the primary endpoint in the Phase III STATUS trial to treat super-refractory status epilepticus (SRSE). SRSE is a persistent state of seizure that does not respond to first-, second- or third-line treatments and for which there are no approved therapies.

In the 132-patient trial, 43.9% of patients who received IV brexanolone were successfully weaned from third-line agents and remained free of status epilepticus activity for at least the 24 hours following the end of treatment without the need to reinstate third-line agents vs. 42.4% of patients who received placebo (p=0.8775). STATUS, which was conducted under an SPA from FDA, enrolled patients ages two and older on third-line standard of care (SOC) anti-seizure agents to receive brexanolone or placebo for six days...