US-based biopharmaceutical firm Sage Therapeutics has begun dosing healthy volunteers in its Phase I clinical trial of SAGE-718.
SAGE-718 is an oral, oxysterol-based, N-methyl-D-aspartate (NMDA) receptor, positive allosteric modulator (PAM).
The positive modulation of NMDA receptors reportedly has the potential for treating disorders characterised by cognitive, neurological and behavioural symptoms.
The double-blind, placebo-controlled, single ascending dose Phase I trial is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the product when administered orally.
Sage chief executive officer Jeff Jonas said: “Advancing SAGE-718 into Phase I clinical development represents a significant achievement in broadening our clinical pipeline beyond GABA, with a new product development platform focused on a novel mechanism to modulate the NMDA receptor system.
“Loss of NMDA function may have a significant impact in many neuro psych disorders, and SAGE-718 and our novel follow-on compounds have the potential to further extend our pipeline into a broad array of CNS indications."
According to the data from preclinical studies, SAGE-718 showed improved social behaviour in animal model with NMDA hypofunction, and mitigated deficits associated with behavioural and electrophysiological in a model with irregular cholesterol regulation.
The top-line results from the Phase I trial are expected to be available in the second half of this year.
Sage develops medicines for central nervous system (CNS) disorders, targeting GABA and NMDA receptor systems.
Image: Sage Therapeutics' new trial for SAGE-718. Photo: courtesy of foto76/FreeDigitalPhotos.net.