Axsome Therapeutics Provides Year End 2018 Clinical Update
Phase 2 results of AXS-05 in major depressive disorder on track for early
Phase 3 results of AXS-05 in treatment resistant depression on track for 1Q 2019
Phase 3 trial of AXS-07 in acute migraine on track to start in 1Q 2019
Axsome is evaluating AXS-05 (dextromethorphan/bupropion) in the following indications: treatment resistant depression, major depressive disorder, Alzheimer’s disease agitation, and smoking cessation.
Treatment Resistant Disorder
To date, just under 90% of the target number of subjects have been randomized in the Phase 3 STRIDE-1 trial in treatment resistant depression (TRD), with topline results anticipated in the first quarter of 2019. STRIDE-1 is a multicenter, randomized, double-blind, controlled trial in which subjects with TRD are randomized to treatment with AXS-05 or bupropion. A positive interim futility analysis was previously announced for the STRIDE-1 trial. The interim analysis was conducted by an independent data monitoring committee (IDMC) which recommended continuation of the study. Axsome has received
Major Depressive Disorder
Axsome has completed enrollment in the Phase 2 ASCEND study in major depressive disorder (MDD), and is on track to announce topline results in early
Alzheimer’s Disease Agitation
AXS-05 is being evaluated in a Phase 2, randomized, double-blind, controlled trial for smoking cessation treatment. In the trial, smokers are randomized to treatment with AXS-05 or bupropion. The trial is being conducted under a research collaboration between
Axsome is developing AXS-07 (MoSEIC meloxicam/rizatriptan) 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. The Phase 3 trial will be a multicenter, randomized, double-blind, controlled trial in which subjects with migraine are randomized to treatment with AXS-07, meloxicam, rizatriptan, or placebo.
Axsome is developing AXS-12 (reboxetine) for the treatment of narcolepsy.
Anticipated Clinical Trial Readouts
- Phase 2 ASCEND trial of AXS-05 in MDD, topline data (early
- Phase 3 STRIDE-1 trial of AXS-05 in TRD, topline data (1Q 2019)
- Phase 2 trial of AXS-05 in smoking cessation, topline data (1Q 2019)
- Phase 2 trial of AXS-12 in narcolepsy, topline data (1H 2019)
- Phase 2/3 ADVANCE-1 trial of AXS-05 in AD agitation, interim efficacy analysis (2019)
- Phase 2/3 ADVANCE-1 trial of AXS-05 in AD agitation, topline data (2H 2019 – 1H 2020)
- Phase 3 trial of AXS-07 in the acute treatment of migraine, topline data (2019)
AXS-05 is a novel, oral, investigational medicine under development for the treatment of central nervous system (CNS) disorders. AXS-05 consists of bupropion and dextromethorphan and utilizes Axsome’s metabolic inhibition technology. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is an investigational drug product not approved by the
AXS-07 is a novel, oral, rapidly absorbed, investigational medicine consisting of MoSEIC™ meloxicam and rizatriptan. AXS-07 utilizes Axsome’s proprietary MoSEIC™ (
AXS-12 (reboxetine) is a novel, oral, investigational medicine in development for the treatment of the symptoms of narcolepsy. AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor. AXS-12 is an investigational drug product not approved by the
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the trials, futility analyses and receipt of interim results, which are not necessarily indicative of the final results of our ongoing clinical trials; our ability to fund additional clinical trials to continue the advancement of our product candidates; the timing of and our ability to obtain and maintain
Source: Axsome Therapeutics, Inc.