Axsome: IDMC recommends continuation of trial evaluating AXS-05 in AD
Axsome Therapeutics announced a positive outcome of the interim analysis for the ADVANCE-1 Phase 2/3 trial of AXS-05 in agitation associated with Alzheimer's disease An independent data monitoring committee conducted the unblinded, pre-specified interim analysis for futility. Based on the results of the analysis, the IDMC recommended continuation of the AXS-05 treatment arm. Additionally, the IDMC recommended no further randomization of subjects to the bupropion treatment arm of the study. The IDMC did not indicate that there were any safety concerns in the study. Axsome intends to follow the IDMC's recommendations. AXS-05 is a novel, oral, investigational medicine consisting of dextromethorphan and bupropion. Patients in the ADVANCE-1 trial were being randomized in a 1:1:1 ratio to treatment with AXS-05, placebo, or bupropion. The primary endpoint of the study is the change in the Cohen Mansfield Agitation Inventory for AXS-05 as compared to placebo. The single-agent bupropion arm of the study was included to compare the efficacy of AXS-05 to the bupropion component, with the goal of demonstrating the superiority of AXS-05, as required by the U.S. Food and Drug Administration's combination product rule. In accordance with the IDMC's recommendation, the study will now continue enrollment in a 1:1 ratio to only the AXS-05 and placebo arms. The ADVANCE-1 interim futility analysis was performed on the first approximately 30% of the target number of subjects.