Axsome Therapeutics, Inc. ( AXSM Quick Quote AXSM - Free Report) announced that its novel, oral, multi-mechanistic investigational candidate, AXS-07, met the two regulatory co-primary endpoints in a late-stage study.
The phase III MOMENTUM study was a randomized, double-blind, placebo- and active-controlled trial, which enrolled only patients with a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire (mTOQ-4). The study was conducted pursuant to an FDA Special Protocol Assessment (SPA).
A total of 1,594 patients were randomized in a 2:2:2:1 ratio to AXS-07 (20 mg MoSEIC meloxicam/10 mg rizatriptan), Maxalt, MoSEIC meloxicam (20 mg), or placebo, to treat a single migraine attack of moderate or severe intensity. Additionally, the enrolled patients exhibited a high rate of characteristics that are strongly associated with poor treatment outcomes, including cutaneous allodynia (75.4%), severe migraine pain intensity (41.2%), obesity (43.7%) and morning migraine (36.6%).
Maxalt (rizatriptan), an active comparator in the trial, is considered to be the fastest acting oral triptan and one of the most effective medications currently available for the acute treatment of migraine.
Results showed that AXS-07 met the two regulatory, co-primary endpoints and significantly improved migraine pain and most trouble symptoms as compared to placebo. The candidate also met the key secondary endpoint, demonstrating statistically significant superiority to the active comparator rizatriptan on sustained freedom from migraine pain. A greater percentage of patients achieved pain freedom and absence of most bothersome symptom with AXS-07 after two hours of dosing as compared to placebo. The candidate was safe and well tolerated in the trial.
Hence, the positive results on both co-primary endpoints along with the demonstration of component contribution support the filing of an NDA for AXS-07 in the acute treatment of migraine. Per its discussions with the FDA, Axsome believes that MOMENTUM will be the only efficacy study required to support an NDA filing for the same. The company plans to file the NDA in the second half of 2020.
The successful development and commercialization of the candidate will be a significant boost for this clinical-stage biopharmaceutical company. AXS-07 is currently in two phase III studies for the same indication.
The company’s shares have skyrocketed 3581.9% in the past year compared with the
industry’s growth of 7.7%.
Axsome is developing novel therapies for the management of central nervous system (CNS) disorders, for which there are limited treatment options. Apart from ASX-07, the company’s core CNS product portfolio includes three clinical-stage candidates — AXS-05, AXS-09 and AXS-12. AXS-05 is currently in a phase III study for treatment resistant depression (TRD), a phase II/III study in agitation associated with Alzheimer’s disease (AD). AXS-05 is also being developed for smoking cessation treatment and for major depressive disorder (MDD). AXS-12 is being developed for the treatment of narcolepsy.
The FDA recently approved Allergan’s
AGN Ubrelvy (ubrogepant) for the acute treatment of migraine with or without aura in adults. Other approved drugs include Eli Lilly’s LLY Emgality and Teva Pharma’s TEVA Ajovy.
Axsome currently carries a Zacks Rank #3 (Hold). You can see
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