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Corporate News Blog - Sage Therapeutics Announces Top-Line Results from Phase-3 STATUS Trial of Brexanolone

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LONDON, UK / ACCESSWIRE / September 14, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Sage Therapeutics, Inc. (NASDAQ: SAGE), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=SAGE. The Cambridge based Company announced on September 12, 2017, that top-line results from its Phase-3 STATUS Trial of brexanolone (SAGE-547) in the treatment super-refractory status epilepticus (SRSE) indicate that the Company has failed to meet the main goal, comparing success in weaning of third-line agents and resolution of potentially life-threatening status epilepticus with brexanolone versus placebo, when added to standard-of-care. For immediate access to our complimentary reports, including today's coverage, register for free now at:


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  • The STATUS Trial was conducted under a Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA).
  • The trial was designed to evaluate the efficacy and safety of brexanolonein patients with SRSE, aged two years or older, in the US, Canada, and Europe.
  • In the double-blind trial, 132 patients were randomized to receive either brexanolone or placebo in addition to standard-of-care third-line anti-seizure agents for six days.
  • Patients who failed to respond to brexanolone or placebo were subsequently eligible for an open-label infusion of brexanolone at a higher dose over a 6-day period.

Trial helped in Understanding GABA Mechanisms Thoroughly

Jeff Jonas, M.D., Chief Executive Officer of Sage Therapeutics, said that he is proud of the Sage team for making a significant progress in understanding how to best treat critically ill patients. He added that although the Company 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 the understanding of GABA mechanisms and their effect on brain circuitry.

Trial Represents a Significant Contribution to SRSE Research

Eric Rosenthal, M.D., Co-Principal Investigator of the STATUS Trial, stated that SRSE is an extremely complicated condition to treat and there is a significant unmet need for new treatments. He added that a lot has been learned from the STATUS Trial, that represents a significant contribution to SRSE research and he hopes these data will provide a foundation for the development of future treatments for patients with this devastating condition.

Findings of the STATUS Trial

  • 43.9% patients treated with brexanolone and 42.4% patients treated with placebo successfully weaned from third-line agents during the double-blind period.
  • Secondary endpoint results were found to be consistent with the primary endpoint.
  • 37% patients treated with open-label brexanolone achieved treatment response, post double-blind period
  • Almost all patients experienced adverse events that were similar between the two treatment groups.

About Super-refractory Status Epilepticus

Status epilepticus (SE) is when a seizure lasts longer than 5 minutes or when seizures occur close together and the person does not recover between seizures. An SE patient is first treated with benzodiazepines, and if no response, is then treated with other, second-line, anti-seizure drugs. SRSE is a medical emergency in which patients experience continuous seizures that do not stop even after standard treatment attempts in the ICU have not been effective in controlling the ongoing seizure. There are no treatments for SRSE currently approved by FDA.

About Brexanolone (SAGE-547)

Brexanolone is an allosteric modulator of both synaptic and extrasynaptic GABAA receptors. Brexanolone is an intravenous agent that was evaluated as an adjunctive therapy for the treatment of SRSE in the global Phase-3 STATUS Trial. Brexanolone is also being developed for the treatment of postpartum depression (PPD).

Last Close Stock Review

Sage Therapeutics' share price finished yesterday's trading session at $70.37, sliding 7.89%. A total volume of 2.95 million shares have exchanged hands, which was higher than the 3-month average volume of 467.08 thousand shares. The Company's stock price skyrocketed 1.16% in the past six months and 71.30% in the previous twelve months. Additionally, the stock soared 37.82% since the start of the year. The stock currently has a market cap of $2.62 billion.

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