Axsome Therapeutics, Inc. has successfully completed its phase 3 clinical program for AXS-05 in treating Alzheimer’s disease agitation. The ACCORD-2 trial achieved the primary endpoint by statistically significantly delaying the time to relapse of agitation compared to placebo, with a 3.6-fold lower risk of relapse. Additionally, AXS-05 met the key secondary endpoint, and reduced overall Alzheimer’s disease severity compared to placebo. The ADVANCE-2 trial did not demonstrate statistical significance for the primary endpoint, although numerically greater improvements were observed with AXS-05 over placebo for both primary and secondary endpoints.
In terms of safety, AXS-05 was well tolerated in both controlled and long-term trials and was not associated with death, increased risk of falls, cognitive decline, or sedation. The long-term safety trial, involving over 300 subjects treated for at least 6 months and over 100 subjects treated for at least 12 months, demonstrated a safety profile consistent with short-term trials and no new safety signals identified.
The comprehensive clinical development program of AXS-05 in Alzheimer’s disease agitation includes four completed pivotal, phase 3, placebo-controlled trials. AXS-05 has been granted breakthrough therapy designation for the treatment of Alzheimer’s disease agitation, and the company plans to submit a new drug application (NDA) to the FDA in the second half of 2025 based on the efficacy and safety data from the trials.
Today the company's shares have moved -10.2% to a price of $77.82. Check out the company's full 8-K submission here.
