Er komen op korte termijn veel fase 2/3 resultaten:
NEW YORK, Dec. 27, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today provided the following clinical update for its robust CNS pipeline:
AXS-05
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 U.S. Food and Drug Administration (FDA) Fast Track designation for AXS-05 for the treatment of TRD.
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 January 2019, as previously disclosed. ASCEND is a multicenter, randomized, double-blind, controlled trial in which subjects with MDD are randomized to treatment with AXS-05 or bupropion.
Alzheimer’s Disease Agitation
In December 2018, Axsome announced positive results of an interim futility analysis for the Phase 2/3 ADVANCE-1 trial of AXS-05 in Alzheimer’s disease (AD) agitation. ADVANCE-1 is a multicenter, randomized, double-blind, controlled trial in which subjects with agitation associated with Alzheimer’s disease are randomized to treatment with AXS-05, bupropion or placebo. 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.
Smoking Cessation
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 Duke University and Axsome. Top-line results are anticipated in the first quarter of 2019, as previously disclosed.
AXS-07
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.
AXS-12
Axsome is developing AXS-12 (reboxetine) for the treatment of narcolepsy.
In December 2018, Axsome received Investigational New Drug Application (IND) clearance to proceed with its planned Phase 2 trial of AXS-12 (reboxetine) in narcolepsy from the FDA. The planned Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled, crossover study in patients with narcolepsy. Axsome anticipates initiation of this study in January 2019, with topline results in the first half of 2019. Axsome has received FDA Orphan Drug Designation for AXS-12 for the treatment of narcolepsy.
Anticipated Clinical Trial Readouts
Phase 2 ASCEND trial of AXS-05 in MDD, topline data (early January 2019)
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)
About AXS-05
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 FDA. The safety and efficacy of AXS-05 have not yet been established.
About AXS-07
AXS-07 is a novel, oral, rapidly absorbed, investigational medicine consisting of MoSEIC™ meloxicam and rizatriptan. AXS-07 utilizes Axsome’s proprietary MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) technology to substantially increase the solubility and speed the absorption of meloxicam while maintaining durability of action.
About AXS-12
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 FDA.
About Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Axsome’s core CNS product candidate portfolio includes four clinical-stage candidates, AXS-05, AXS-07, AXS-09, and AXS-12. AXS-05 is currently in a Phase 3 trial in treatment resistant depression (TRD), a Phase 2/3 trial in agitation associated with Alzheimer’s disease (AD), a Phase 2 trial in Major Depressive Disorder (MDD), and a Phase 2 trial in smoking cessation. AXS-07 is being developed for the acute treatment of migraine. AXS-12 is being developed for the treatment of the symptoms of narcolepsy. The Axsome Pain and Primary Care business unit (Axsome PPC) houses Axsome’s pain and primary care assets, including AXS-02 and AXS-06, and intellectual property which covers these and related product candidates and molecules being developed by Axsome and others. AXS-02 is being developed for osteoporosis, the pain of knee osteoarthritis, and chronic low back pain. AXS-06 is being developed for osteoarthritis and rheumatoid arthritis. AXS-02, AXS-05, AXS-06, AXS-07, AXS-09, and AXS-12 are investigational drug products not approved by the FDA. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.