Clinical-stage biopharmaceutical firm Sage Therapeutics has dosed the first patient in phase 2 proof-of-concept trial of SAGE-217 in Parkinson's disease (PD)
SAGE-217 is a next generation positive allosteric modulator that has been optimized for selectivity to synaptic and extrasynaptic GABA receptors and a pharmacokinetic profile aimed for daily oral dosing.
The two-part phase 2 trial will assess the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in moderate PD patients.
Part A of the study will be an open-label, proof-of-concept trial, which will evaluate SAGE-217 in about 18 patients. If promising, the study may be progressed to a randomized, placebo-controlled phase 2 trial.
It will also assess improvement in motor symptoms as evaluated by the change from baseline after one week in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part 3 (Motor Examination) total score.
Apart from PD, patients screening is underway for a phase 2a study in patients with essential tremor (ET).
Top-line data from the PD study are expected in the first half of 2017 followed by results in the ET study in the second half.
The company also aims to start phase 2 clinical trials of SAGE-217 in two mood disorders - major depressive disorder and postpartum depression.
Sage Therapeutics chief medical officer Steve Kanes said: "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."
http://clinicaltrials.pharmaceutical-business-review.com/news/sage-therapeutics-starts-phase-2-study-of-sage-217-in-movement-disorders-141216-5696399
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