SAGE Therapeutics Inc. (NASDAQ: SAGE) share prices fell heavily after the company disclosed that its Phase 3 STATUS trial of brexalonone in super-refractory status epilepticus (SRSE) did not meet its primary endpoint.
A release posted Tuesday by the Cambridge, Mass.-based drug maker also said demographics and baseline characteristics were well-balanced between treatment groups in the study.
Due to the severity and complexity of their underlying medical conditions, serious adverse events commonly occur in patients with SRSE and were similar in frequency and type between the two treatment groups. SRSE, 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.
The release also said there remain no treatments for SRSE currently approved by the U.S. Food and Drug Administration (FDA).
Even so, Sage CEO Jeff Jonas put the best spin he could on the tidings, saying “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.”
The STATUS Trial was conducted under a Special Protocol Assessment agreement with the FDA and was designed to evaluate the efficacy and safety of brexanolone in patients with SRSE, ages two years or older, in the U.S., Canada and Europe.
The reverberations were heard among investors, who fled the stock in droves, lowering the price by $12.99, or 14.7%, to $75.53.
