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Sage Therapeutics Gets Fast Track Designation For SAGE-718 From FDA - Quick Facts

Biopharmaceutical company Sage Therapeutics, Inc. (SAGE) announced Wednesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SAGE-718 for development as a potential treatment for Huntington's disease (HD).

Fast Track is a process designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as HD. It provides opportunities to engage collaboratively with the FDA to further clinical development and future regulatory review.

HD is an autosomal dominant genetic disorder that impacts the brain and by nature numerous generations of a family. Cognitive decline is often one of the earliest signs of the disease.

In studies to date, treatment with SAGE-718 has been associated with improved cognitive performance, particularly in the domain of executive functioning.

SAGE-718, Sage's first-in-class NMDA receptor PAM and lead neuropsychiatric drug candidate, is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, potentially including HD, Parkinson's disease and Alzheimer's disease.

Sage expects to initiate a placebo-controlled Phase 2 trial with SAGE-718 in early to moderate HD in late 2021.

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