Axsome Therapeutics (AXSM) announced this morning that while the ACCORD-2 Phase 3 trial achieved the primary endpoint with AXS-05 statistically delayed the time to relapse of agitation in patients with Alzheimer’s disease compared to placebo, the ADVANCE-2 Phase 3 trial did not demonstrate statistical significance for the primary endpoint, change in the CMAI total score from baseline to week five. The ADVANCE-2 trial was a double-blind, placebo-controlled, parallel group trial of AXS-05 in Alzheimer’s disease patients with agitation. A total of 408 patients were randomized in a 1:1 ratio to treatment with AXS-05 or placebo, for five weeks. The study did not demonstrate statistical significance for the primary endpoint. The overall rates of adverse event in ADVANCE-2 were 26.0% in the AXS-05 group and 21.6% in the placebo group. Axsome plans to submit a new drug application for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from these studies. Shares of Axsome Therapeutics are down 8%, or $6.71, to $80.00 in premarket trading.
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