Sage Therapeutics Announces Initiation of Phase 2 Clinical Development for SAGE-217 in Movement Disorders
Wednesday, December 14, 2016
Sage Therapeutics, a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced the initiation of Phase 2 clinical development of SAGE-217, a novel, internally-developed, next generation oral GABAA receptor modulator that Sage is developing in both mood and movement disorders. Dosing has now been initiated in the first of two movement disorder indications. Patients are receiving SAGE-217 in a Phase 2 proof-of-concept trial in Parkinson's disease. In addition, trial sites are open and screening patients for a Phase 2a trial in essential tremor. Patients in this trial are expected to be dosed imminently. Top-line results from the Part A open-label study in Parkinson's disease are expected in the first half of 2017 and the essential tremor study is anticipated to report results in the second half of 2017. The Company also plans to initiate Phase 2 clinical trials of SAGE-217 in two mood disorders - major depressive disorder (MDD) and postpartum depression (PPD).
"Sage continues to pioneer innovative approaches to neuroscience drug development in CNS indications with high unmet need where we can redefine treatment paradigms," said Jeff Jonas, M.D., Chief Executive Officer of Sage. "The SAGE-217 clinical program is an excellent example of this approach. The initiation of mid-stage trials of our novel, proprietary oral compound is a significant corporate milestone and a credit to our talented team of translational chemists, and clinical and regulatory leaders."
"Administering the first dose of SAGE-217 in a proof-of-concept study in Parkinson's disease and the initiation of SAGE-217 in essential tremor illustrate major progress in Sage's effort to address the serious need for additional effective treatments for these movement disorders and in building our multi-product, neuropsych portfolio," said Steve Kanes, M.D., Ph.D., Chief Medical Officer of Sage. "SAGE-217 is one of several product candidates that Sage is developing to target the GABAA receptor system. Dysfunction in this system is thought to be at the core of numerous psychiatric and neurological disorders including essential tremor and both the motor and non-motor symptoms in Parkinson's disease."
The essential tremor study is a Phase 2a double-blind, placebo-controlled, randomized withdrawal study that will evaluate the efficacy, safety, tolerability and pharmacokinetics of SAGE-217 in approximately 60 patients with essential tremor. The primary endpoint of the study is to compare the effect of one week of SAGE-217 on overall kinetic tremor symptoms. Secondary endpoints include additional accelerometer-derived and clinician-rated rating scales.
The Parkinson's disease program is a two-part Phase 2 clinical trial evaluating the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in moderate Parkinson's disease patients. Part A of the Phase 2 trial will be an open-label, proof-of-concept study evaluating SAGE-217 in approximately 18 patients which, if promising, may lead to a randomized, placebo-controlled Phase 2 trial. The primary endpoint for the Part A study will be to evaluate the safety and tolerability of SAGE-217. The secondary endpoint will be to evaluate improvement in motor symptoms as assessed by the change from baseline after one week in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 (Motor Examination) total score.
