SAGE Receives Special Protocol Assessment for Phase 3 STAT-Refractory Status EpileUS Trial of SAGE-547 in Superpticus

SAGE Therapeutics

today announced it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the STATUS Trial (SAGE-547 Treatment as Adjunctive Therapy Utilized in Status Epilepticus), a global, Phase 3, randomized, double-blind, placebo-controlled clinical trial to evaluate SAGE-547 as a treatment for patients with super-refractory status epilepticus (SRSE). The SPA provides agreement from the FDA that the Phase 3 STATUS Trial can adequately address objectives in support of a U.S. regulatory submission for approval of SAGE-547 for the treatment of patients with SRSE. SRSE is a rare, life-threatening condition of persistent, unremitting seizure, for which there are no approved therapies. "This is a major accomplishment for SAGE Therapeutics. By obtaining FDA agreement on the Phase 3 STATUS Trial design, endpoints, patient population and statistical approach, we have a clear path on moving forward with our development and regulatory plan for SAGE-547 in SRSE. As first movers in seeking a treatment for this life-threatening disorder, we believe our SPA is an important mechanism to further de-risk our development pathway. We look forward to enrolling patients in the Phase 3 STATUS Trial imminently," said