Sage Therapeutics has started a Phase 2 clinical trial of its drug candidate SAGE-217 in both mood and movement disorders. The first patients have been dosed with SAGE-217 in the proof-of-concept trial evaluating the drug in patients with Parkinson’s disease (PD).
The company also announced it has started recruiting patients for a Phase 2a trial in patients with essential tremor.
Data from the Part A open-label trial in Parkinson’s disease should be available early next year, while results from the essential tremor trial should be reported in mid-2017.
SAGE is also planning to begin Phase 2 clinical trials of SAGE-217 in patients with major depressive disorder (MDD) and in women with postpartum depression (PPD) (NCT02978326).
“Sage continues to pioneer innovative approaches to neuroscience drug development in CNS indications with high unmet need where we can redefine treatment paradigms,” Sage CEO Jeff Jonas, MD, said in a press release. “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.”
SAGE-217 is a first-in-class compound that selectivity targets synaptic and extrasynaptic GABA receptors, which are important in cognition. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system, and contributes significantly to regulating CNS function.
“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,” Kanes said.
The essential tremor study is double-blind, randomized withdrawal, Phase 2a (NCT02978781) clinical trial that will evaluate the safety, tolerability, effectiveness, and drug properties of SAGE-217 (oral solution) in 80 participants with essential tremor. The primary endpoint is the effect of seven days administration of the drug compared to a placebo on the change in accelerometer-based kinetic tremor combined score.
The Parkinson’s trial has two parts. Part A is an open-label study with morning dosing of SAGE-217 for seven days in 18 Parkinson’s patients. If results are positive, patients will move to Part B, where they will be randomly assigned to morning or evening dosing of SAGE-217 or a placebo for up to seven days.
The primary endpoint of Part A is the assessment of SAGE-217’s safety and tolerability. The secondary endpoint is the assessment of improvements in motor symptoms (change from baseline after seven days in the motor examination domain score of the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale, or MDS-UPDRS).
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