Axsome says Phase 2, Phase 3 trials of AXS-05 on track for early 2019 readouts

Axsome Therapeutics provided a clinical update for its CNS pipeline, stating that just under 90% of the target number of subjects have been randomized in the Phase 3 STRIDE-1 trial in treatment resistant depression to date, with topline results anticipated in the first quarter of 2019. Axsome also said it has completed enrollment in the Phase 2 ASCEND study in major depressive disorder and is on track to announce topline results in early January 2019, as previously disclosed. In December, Axsome announced results of an interim futility analysis for the Phase 2/3 ADVANCE-1 trial of AXS-05 in Alzheimer’s disease agitation. The interim analysis was conducted by an IDMC which recommended continuation of the AXS-05 treatment arm and no further randomization of subjects to the bupropion treatment arm. Axsome intends to follow the IDMC’s recommendation. Axsome has received FDA Fast Track designation for AXS-05 for the treatment of AD agitation. AXS-05 is also being evaluated in a Phase 2, randomized, double-blind, controlled trial for smoking cessation treatment. Top-line results are anticipated in the first quarter of 2019, as previously disclosed. Axsome is developing AXS-07 for the acute treatment of migraine.Axsome anticipates initiation of its planned Phase 3 trial of AXS-07 in patients with migraine in the first quarter of 2019, as previously disclosed, with topline results expected within approximately one year from trial initiation.
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