SAGE-547 Shows 77% Response Rate; SAGE Plans Phase 3 Trial By Mid-2015

(RTTNews) - SAGE Therapeutics (SAGE) announced that SAGE-547 demonstrated robust activity, with a 77 percent response rate in evaluable patients with super-refractory status epilepticus, or SRSE, in a Phase 1/2 clinical trial. The trial evaluated the safety, efficacy, tolerability and pharmacokinetics of two IV-administered dose regimen cohorts of SAGE-547 as an adjunctive therapy for the treatment of patients with SRSE at 18 trial sites in the United States.

The company reported that SAGE-547 demonstrated favorable tolerability and a benefit-risk profile supporting development in this patient population.

SAGE plans to initiate the STATUS Trial, a Phase 3 randomized, double-blind, placebo-controlled clinical trial of SAGE-547 for the treatment of patients with SRSE, by mid-2015.