Sage Therapeutics is beginning studies to explore the use of SAGE-217 in patients with Parkinson’s disease and essential tremors.
Sage Therapeutics recently announced the start of a phase 2 clinical trial evaluating the drug SAGE-217 in movement disorders, such as Parkinson’s disease and essential tremor.
SAGE-217 is a next generation oral GABAA receptor modulator that is being developed to treat multiple mood and movement disorders, according to a press release from Sage Therapeutics.
Dosing has already begun in the proof-of-concept trial, which includes patients with Parkinson’s disease. Dosing is expected to begin shortly among patients in the phase 2a trial for patients with essential tremor.
Sage is expecting top-line results from the first part of the study involving Parkinson’s disease within the first half of 2017, and results from the essential tremor study are expected in the second half of the year, according to the press release.
The company also is planning to explore the use of SAGE-217 in patients with mood disorders, such as major depressive disorder and postpartum depression.
"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, MD, PhD, 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 phase 2a study will determine the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in 60 patients with essential tremor. The primary endpoint is to compare the effects of the drug on kinetic tremor symptoms, and secondary endpoints include accelerometer-derived and clinician-rated rating scales, according to the press release.
The Parkinson’s disease study will be evaluating the same aspects of the drug in 18 patients with moderate Parkinson’s disease. If successful, Sage plans to move the drug to a randomized, placebo-controlled phase 2 trial.
The primary endpoint of the study will be to evaluate safety and tolerability, and secondary endpoints will be to evaluate the improvement in motor symptoms by the change from initiation to 1 week of treatment, according to the press release.
"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, MD, 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."