Biopharmaceutical company Axsome Therapeutics Inc, which focuses on the management of central nervous system disorders, has enrolled the first patient in SYMPHONY (Study Evaluating a Mechanistic Approach to Treating Narcolepsy), a Phase 3, randomized, double-blind, placebo-controlled trial of AXS-12 in patients with narcolepsy. Topline results from the SYMPHONY trial are anticipated in the first half of 2023.

“The advancement of AXS-12 into Phase 3 testing for narcolepsy demonstrates Axsome’s commitment to developing important new medicines for patients living with serious CNS conditions,” says Herriot Tabuteau, MD, Axsome CEO, in a release. “Narcolepsy impairs almost every aspect of a patient’s life including cognitive, psychological, social, and emotional functioning. If successfully developed, AXS-12 may address multiple symptoms of this debilitating condition.”

AXS-12 has been granted Orphan Drug Designation by the US Food and Drug Administration for the treatment of narcolepsy.

SYMPHONY will include approximately 90 patients, who will be randomized in a 1:1 ratio to treatment with AXS-12 or placebo for 5 weeks. The primary endpoint will be the frequency of cataplexy attacks. Other symptoms of narcolepsy as well as safety will be assessed throughout the study.

AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor under development for the treatment of narcolepsy. AXS-12 modulates noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognition. AXS-12 is an investigational drug product not approved by the FDA.