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FDA approval of IND accustomed for Phase 2 balloon of AXS-12 in narcolepsy

Phase 2 after-effects of AXS-05 in above depressive ataxia on clue for aboriginal January 2019

Phase 3 after-effects of AXS-05 in assay aggressive abasement on clue for 1Q 2019

Phase 3 balloon of AXS-07 in astute cephalalgia on clue to alpha in 1Q 2019
NEW YORK, Dec. 27, 2018 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical aggregation developing atypical therapies for the administration of axial afraid arrangement (CNS) disorders, today provided the afterward analytic amend for its able-bodied CNS pipeline:

AXS-05

Axsome is evaluating AXS-05 (dextromethorphan/bupropion) in the afterward indications: assay aggressive depression, above depressive disorder, Alzheimer’s ache agitation, and smoker cessation.

Treatment Aggressive Disorder

To date, aloof beneath 90% of the ambition cardinal of capacity accept been randomized in the Phase 3 STRIDE-1 balloon in assay aggressive abasement (TRD), with topline after-effects advancing in the aboriginal division of 2019. STRIDE-1 is a multicenter, randomized, double-blind, controlled balloon in which capacity with TRD are randomized to assay with AXS-05 or bupropion. A absolute acting futility assay was ahead appear for the STRIDE-1 trial. The acting assay was conducted by an absolute abstracts ecology board (IDMC) which recommended assiduity of the study. Axsome has accustomed U.S. Food and Biologic Administration (FDA) Fast Clue appellation for AXS-05 for the assay of TRD.

Major Depressive Disorder

Axsome has completed accepting in the Phase 2 ASCEND abstraction in above depressive ataxia (MDD), and is on clue to advertise topline after-effects in aboriginal January 2019, as ahead disclosed. ASCEND is a multicenter, randomized, double-blind, controlled balloon in which capacity with MDD are randomized to assay with AXS-05 or bupropion.

Alzheimer’s Ache Agitation

In December 2018, Axsome appear absolute after-effects of an acting futility assay for the Phase 2/3 ADVANCE-1 balloon of AXS-05 in Alzheimer’s ache (AD) agitation. ADVANCE-1 is a multicenter, randomized, double-blind, controlled balloon in which capacity with agitation associated with Alzheimer’s ache are randomized to assay with AXS-05, bupropion or placebo. The acting assay was conducted by an IDMC which recommended assiduity of the AXS-05 assay arm and no added randomization of capacity to the bupropion assay arm. Axsome intends to chase the IDMC’s recommendation. Axsome has accustomed FDA Fast Clue appellation for AXS-05 for the assay of AD agitation.

Smoking Cessation

AXS-05 is actuality evaluated in a Phase 2, randomized, double-blind, controlled balloon for smoker abeyance treatment. In the trial, smokers are randomized to assay with AXS-05 or bupropion. The balloon is actuality conducted beneath a assay accord amid Duke University and Axsome. Top-line after-effects are advancing in the aboriginal division of 2019, as ahead disclosed.

AXS-07

Axsome is developing AXS-07 (MoSEIC meloxicam/rizatriptan) for the astute assay of migraine.

Axsome anticipates admission of its planned Phase 3 balloon of AXS-07 in patients with cephalalgia in the aboriginal division of 2019, as ahead disclosed, with topline after-effects accepted aural about one year from balloon initiation. The Phase 3 balloon will be a multicenter, randomized, double-blind, controlled balloon in which capacity with cephalalgia are randomized to assay with AXS-07, meloxicam, rizatriptan, or placebo.

AXS-12

Axsome is developing AXS-12 (reboxetine) for the assay of narcolepsy.

In December 2018, Axsome accustomed Investigational New Biologic Application (IND) approval to advance with its planned Phase 2 balloon of AXS-12 (reboxetine) in narcolepsy from the FDA. The planned Phase 2 balloon is a multicenter, randomized, double-blind, placebo-controlled, crossover abstraction in patients with narcolepsy. Axsome anticipates admission of this abstraction in January 2019, with topline after-effects in the aboriginal bisected of 2019. Axsome has accustomed FDA Orphan Biologic Appellation for AXS-12 for the assay of narcolepsy.

Anticipated Analytic Balloon Readouts

Phase 2 ASCEND balloon of AXS-05 in MDD, topline abstracts (early January 2019)

Phase 3 STRIDE-1 balloon of AXS-05 in TRD, topline abstracts (1Q 2019)

Phase 2 balloon of AXS-05 in smoker cessation, topline abstracts (1Q 2019)

Phase 2 balloon of AXS-12 in narcolepsy, topline abstracts (1H 2019)

Phase 2/3 ADVANCE-1 balloon of AXS-05 in AD agitation, acting adeptness assay (2019)

Phase 2/3 ADVANCE-1 balloon of AXS-05 in AD agitation, topline abstracts (2H 2019 – 1H 2020)

Phase 3 balloon of AXS-07 in the astute assay of migraine, topline abstracts (2019)

About AXS-05

AXS-05 is a novel, oral, investigational anesthetic beneath development for the assay of axial afraid arrangement (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 access the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is an investigational biologic artefact not accustomed by the FDA. The assurance and adeptness of AXS-05 accept not yet been established.

About AXS-07

AXS-07 is a novel, oral, rapidly absorbed, investigational anesthetic consisting of MoSEIC™ meloxicam and rizatriptan. AXS-07 utilizes Axsome’s proprietary MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) technology to essentially access the solubility and acceleration the assimilation of meloxicam while advance backbone of action.

About AXS-12

AXS-12 (reboxetine) is a novel, oral, investigational anesthetic in development for the assay of the affection of narcolepsy. AXS-12 is a awful careful and almighty norepinephrine reuptake inhibitor. AXS-12 is an investigational biologic artefact not accustomed by the FDA.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical aggregation developing atypical therapies for the administration of axial afraid arrangement (CNS) disorders for which there are bound assay options. Axsome’s amount CNS artefact applicant portfolio includes four clinical-stage candidates, AXS-05, AXS-07, AXS-09, and AXS-12. AXS-05 is currently in a Phase 3 balloon in assay aggressive abasement (TRD), a Phase 2/3 balloon in agitation associated with Alzheimer’s ache (AD), a Phase 2 balloon in Above Depressive Ataxia (MDD), and a Phase 2 balloon in smoker cessation. AXS-07 is actuality developed for the astute assay of migraine. AXS-12 is actuality developed for the assay of the affection of narcolepsy. The Axsome Affliction and Primary Affliction business assemblage (Axsome PPC) houses Axsome’s affliction and primary affliction assets, including AXS-02 and AXS-06, and bookish acreage which covers these and accompanying artefact candidates and molecules actuality developed by Axsome and others. AXS-02 is actuality developed for osteoporosis, the affliction of knee osteoarthritis, and abiding low aback pain. AXS-06 is actuality developed for osteoarthritis and rheumatoid arthritis. AXS-02, AXS-05, AXS-06, AXS-07, AXS-09, and AXS-12 are investigational biologic articles not accustomed by the FDA. For added information, amuse appointment the Company’s website at Media The Aggregation may occasionally advertise material, nonpublic advice on the aggregation website.

Forward Looking Statements

Certain affairs discussed in this columnist absolution are “forward-looking statements”. We may, in some cases, use acceding such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or added words that back ambiguity of approaching contest or outcomes to analyze these advanced statements. In particular, the Company’s statements apropos trends and abeyant approaching after-effects are examples of such advanced statements. The advanced statements accommodate risks and uncertainties, including, but not bound to, the success, timing and amount of our advancing analytic trials and advancing analytic trials for our accepted artefact candidates, including statements apropos the timing of admission and achievement of the trials, futility analyses and cancellation of acting results, which are not necessarily apocalyptic of the final after-effects of our advancing analytic trials; our adeptness to armamentarium added analytic trials to abide the advance of our artefact candidates; the timing of and our adeptness to access and advance U.S. Food and Biologic Administration (“FDA”) or added authoritative ascendancy approval of, or added activity with account to, our artefact candidates (including, but not bound to, FDA’s acceding with the Company’s plan to abandon the bupropion assay arm of the ADVANCE-1 abstraction in accordance with the absolute abstracts ecology committee’s recommendations); the Company’s adeptness to auspiciously avert its bookish acreage or access the all-important licenses at a amount adequate to the Company, if at all; the acknowledged accomplishing of the Company’s assay and development programs and collaborations; the success of the Company’s authorization agreements; the accepting by the bazaar of the Company’s artefact candidates, if approved; and added factors, including accepted bread-and-butter altitude and authoritative developments, not aural the Company’s control. The factors discussed herein could account absolute after-effects and developments to be materially altered from those bidding in or adumbrated by such statements. The advanced statements are fabricated alone as of the date of this columnist absolution and the Aggregation undertakes no obligation to about amend such advanced statements to reflect consecutive contest or circumstance.

Axsome Contact:
Mark Jacobson
Senior Vice President, Operations
Axsome Therapeutics, Inc.
25 Broadway, 9th Floor
New York, NY 10004
Tel: 212-332-3243
Email: Media Media