Axsome Therapeutics presents results of the ACCORD trial of AXS-05

Axsome Therapeutics announced a presentation of data from its ACCORD Phase 3 clinical trial of AXS-05, a novel, oral NMDA receptor antagonist and sigma-1 receptor agonist, in patients with Alzheimer’s disease agitation, at the 16th Clinical Trials on Alzheimer’s Disease (CTAD) Conference, being held in Boston from Oct. 24-27. “Agitation associated with Alzheimer’s dementia is a common and impactful behavioral symptom causing significant distress for patients and their care partners,” said George Grossberg, MD, study author, Professor and Director of the Division of Geriatric Psychiatry at the Saint Louis University School of Medicine. “Agitation is also a significant risk factor for early admission to long term care facilities. The outcome of the ACCORD trial with AXS-05 demonstrating positive efficacy results in agitation associated with Alzheimer’s dementia, while being generally well-tolerated, is welcome news.” Results of the trial demonstrated rapid and sustained clinical response in patients with ADA during the open-label AXS-05 treatment phase. During the placebo-controlled randomized withdrawal phase, AXS-05 statistically significantly delayed the time to relapse of agitation symptoms as compared to placebo. AXS-05 was generally well-tolerated in the trial with no new safety signals identified.