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Axsome Therapeutics Initiates ACCORD Phase 3 Trial of AXS-05 in Alzheimer’s Disease Agitation
ACCORD is the second pivotal trial of AXS-05 in Alzheimer’s disease agitation No treatments are currently approved for Alzheimer’s disease agitation NEW YORK,
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"ACCORD is the second pivotal trial of AXS-05 in Alzheimer’s disease agitation No treatments are currently approved for Alzheimer’s disease agitation NEW YORK, Dec. 31, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, announced the initiation of the ACCORD (Assessing Clinical Outcomes in Alzheimer’s Disease Agitation) study, a Phase 3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AXS-05 in the treatment of Alzheimer’s disease (AD) agitation. AXS-05 (45 mg dextromethorphan-105 mg bupropion modulated delivery tablet) is a novel, oral, investigational NMDA receptor antagonist with multimodal activity. There is currently no approved treatment for AD agitation. ACCORD is being conducted using a randomized-withdrawal design, in which all patients are first treated with open-label AXS-05, with the patients experiencing a treatment response being subsequently randomized in a double-blind fashion to continued treatment with AXS-05 or to switch to placebo. Patients completing the ACCORD trial will be eligible to enter an open-label safety extension trial. Initiation of the safety extension trial is expected imminently. Topline results from the ACCORD trial are anticipated in the second half of 2022. “Initiation of the ACCORD Phase 3 trial in Alzheimer’s disease agitation continues the expedited clinical development of AXS-05 for this serious condition. The potential for AXS-05, with its unique pharmacological profile, in this indication is supported by the positive results in our completed pivotal ADVANCE trial,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Alzheimer’s disease agitation is a prevalent and debilitating condition that is associated with earlier nursing home placement, accelerated progression to severe dementia, and increased risk of death. There are currently no approved treatments for Alzheimer’s disease agitation. If successfully developed, AXS-05 has the potential to address this high unmet need and significantly improve the lives of patients and their caregivers.” Initiation of the ACCORD Phase 3 trial follows a Breakthrough Therapy meeting with the U.S. Food and Drug Administration (FDA), announced in August, to discuss the d...