CAMBRIDGE, Mass., Dec. 15, 2015 (GLOBE NEWSWIRE) -- Sage Therapeutics (SAGE) today announced updated guidance for the expected readout of top-line results for its STATUS Trial (SAGE-547 Treatment as Adjunctive Therapy Utilized in Status Epilepticus), a global, Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating SAGE-547 as a treatment for patients with super-refractory status epilepticus (SRSE). SRSE is a rare, life-threatening condition of persistent seizure where treatment regimens normally sufficient in stopping seizure activity have failed, and for which there are no approved therapies. Top-line results for the Phase 3 clinical trial are now expected in the second half of 2016.
"We are pleased to revise our timeline forward for the Phase 3 STATUS Trial top-line results based on current enrollment trends and our team's continued execution in opening sites. We are excited about the interest in our trial to date," said Jeff Jonas, M.D., Chief Executive Officer of SAGE.
"2016 will be an important and milestone-rich year for SAGE. In the first half of 2016, we expect data readouts from our placebo-controlled Phase 2 trial of SAGE-547 in severe postpartum depression and from the SAGE-217 Phase 1 clinical program. In the second half of the year, in addition to the SAGE-547 Phase 3 data, we expect to launch multiple Phase 2 trials evaluating SAGE-217 in essential tremor, orphan epilepsies and potentially postpartum depression, assuming successful replication of earlier stage work. We also expect to initiate the SAGE-689 Phase 1 development program in the second half of 2016. Along with these clinical milestones, SAGE is also committed to continuing its groundbreaking work studying the NMDA neurotransmitter system and its impact on CNS diseases, and we plan to present additional scientific data on this work in 2016," added Dr. Jonas.
SAGE initiated the Phase 3 STATUS Trial in August 2015. The STATUS Trial is evaluating the efficacy and safety of SAGE-547, and is expected to enroll approximately 126 patients with SRSE, ages two years or older, in the U.S., Canada and Europe. In the double-blind trial, patients are randomized 1:1 to receive either SAGE-547 or placebo in addition to standard-of-care third-line anti-seizure agents for six days. The primary endpoint is successful resolution of status epilepticus (SE) after weaning the patient off all third-line agents, and SAGE-547 or placebo, without resumption of SE within 24 hours after completion of blinded SAGE-547 or placebo administration. The STATUS Trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. SAGE-547 is an intravenous agent in Phase 3 clinical development as an adjunctive therapy for the treatment of super-refractory status epilepticus (SRSE). SAGE-547 has been granted both Fast Track and orphan drug designations by the U.S. Food and Drug Administration (FDA) for the treatment of SRSE. SAGE-547 is being evaluated as a treatment for patients with SRSE in the global Phase 3 STATUS Trial. For more information about the STATUS Trial, please visit www.statustrial.com.