Statistically significant improvement in Alzheimer’s disease agitation, as measured by the CMAI total score compared to placebo (p=0.010, primary endpoint)
Demonstrated rapid and substantial improvement in Alzheimer’s disease agitation starting at week 2 with statistical significance at week 3 compared to placebo (p=0.007)
Statistically significant rates of clinical response (p=0.005) on the CMAI and improvement on the modified Alzheimer’s Disease Cooperative Study-CGIC scale for agitation (p=0.036) compared to placebo
Well-tolerated and not associated with cognitive impairment or sedation
No treatments are currently approved for Alzheimer’s disease agitation
Company to host conference call today at 8:00 AM ET
NEW YORK, April 27, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary endpoint in the ADVANCE-1 Phase 2/3 trial and rapidly, substantially, and significantly improved agitation in patients with Alzheimer’s disease as compared to placebo. The ADVANCE-1 (Addressing Dementia via Agitation-Centered Evaluation) study was a randomized, double-blind, controlled, multicenter, U.S. trial, in which 366 Alzheimer’s disease patients were randomized to treatment with AXS-05 (dextromethorphan/bupropion modulated delivery tablet, dose escalated to 45 mg/105 mg twice daily), bupropion (dose escalated to 105 mg twice daily), or matching placebo, for 5 weeks.
There are currently no FDA-approved treatments for Alzheimer’s disease agitation. Alzheimer’s disease is the most common form of dementia and is characterized by cognitive decline, and behavioral and psychological symptoms including agitation. Agitation is observed in up to 70% of patients with Alzheimer’s disease and is associated with accelerated cognitive decline, earlier nursing home placement, and increased mortality risk [1-3]. AXS-05 has been granted FDA Fast Track designation for the treatment of Alzheimer’s disease agitation.
AXS-05 met the primary endpoint by demonstrating a statistically significant mean reduction in the Cohen Mansfield Agitation Inventory (CMAI) total score compared to placebo at Week 5, with mean reductions from baseline of 15.4 points for AXS-05 and 11.5 points for placebo (p=0.010). These results represent a mean percentage reduction from baseline of 48% for AXS-05 versus 38% for placebo. The CMAI is a 29-item caregiver-rated scale that assesses the frequency of agitation-related behaviors in patients with dementia, including excessive motor activity such as pacing and restlessness, verbal aggression such as screaming and shouting, and physical aggression such as grabbing, pushing, and hitting. AXS-05 was also superior to bupropion on the CMAI total score (p