Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical
company developing novel therapies for the management of central
nervous system (CNS) disorders, today announced that AXS-07, the
Company’s novel, oral, multi-mechanistic investigational medicine
for the acute treatment of migraine, rapidly relieved and
substantially reduced relapse of migraine pain, as compared to the
potent active comparator rizatriptan, in the MOMENTUM Phase 3
trial. These findings were presented at the live sessions of the
2020 American Academy of Neurology (AAN) Science Highlights
platform held virtually September 23-24.
The 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. 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), rizatriptan (10 mg), MoSEIC™ meloxicam (20 mg), or
placebo, to treat a single migraine attack of moderate or severe
intensity. 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 [1-3].
AXS-07 demonstrated faster and more durable
relief of migraine pain as compared to rizatriptan. The probability
of achieving pain relief with AXS-07 was greater than with
rizatriptan within 30 minutes after dosing and at every time point
thereafter, with a median time to migraine pain relief that was
nearly 3x faster for AXS-07 compared to rizatriptan (1.5 vs. 4.0
hours, p<0.001). AXS-07 substantially and significantly reduced
relapse of migraine pain as compared to rizatriptan, with 45.2% of
rizatriptan-treated patients experiencing relapse compared to 21.2%
of AXS-07 patients over 48 hours after dosing (p=0.001).
The results on time to migraine pain relief and
relapse are consistent with the superiority of AXS-07 over
rizatriptan on several other efficacy measures, as previously
reported, including rescue medication use (p<0.001), sustained
pain relief over 24 hours (p=0.006) and 48 hours (p=0.003),
sustained pain freedom over 24 hours (p=0.038) and 48 hours
(p=0.003), Patient Global Impression of Change (p=0.022) at 2
hours, and return to normal functioning at 24 hours (p=0.027). Also
as previously reported, AXS-07 met both co-primary endpoints of the
trial by demonstrating a greater percentage of patients achieving
pain freedom (p<0.001) and absence of most bothersome symptom
(p=0.002), 2 hours after dosing, as compared to placebo.
"The strong efficacy of AXS-07 in patients with
a history of inadequate response is especially notable since it was
demonstrated over one of the most effective triptans,” said Cedric
O’Gorman, MD, Senior Vice President of Clinical Development and
Medical Affairs of Axsome. “With its demonstrated rapid, superior,
and durable effects in the acute treatment of migraine, AXS-07 may
help address the need for more efficacious treatments for this
debilitating neurological condition.”
AXS-07 was safe and well tolerated in the trial.
The most commonly reported adverse events with AXS-07 were nausea,
dizziness and somnolence, none of which occurred at a rate greater
than placebo or greater than 3%.
AXS-07 is a novel, oral, rapidly absorbed,
multi-mechanistic investigational medicine for the acute treatment
of migraine, consisting of MoSEIC™ meloxicam and rizatriptan.
AXS-07 is thought to act by inhibiting CGRP release, reversing
CGRP-mediated vasodilation, and inhibiting neuro-inflammation, pain
signal transmission, and central sensitization. Axsome’s MoSEIC™
technology significantly increases the speed of absorption of the
meloxicam component after oral administration while maintaining a
long plasma half-life. AXS-07 is covered by 44 issued U.S. and
international patents providing protection out to 2036, and Axsome
maintains worldwide rights.
About the
MOMENTUM Trial
MOMENTUM (Maximizing Outcomes in Treating Acute
Migraine) was a Phase 3, randomized, double-blind, multicenter,
controlled trial to assess the efficacy and safety of AXS-07 in the
acute treatment of moderate and severe migraine. Eligible patients
must have had a history of inadequate response to prior acute
migraine treatments, assessed using the Migraine Treatment
Optimization Questionnaire (mTOQ-4). A total of 1,594 patients were
randomized in a 2:2:2:1 ratio to treatment with AXS-07,
rizatriptan, MoSEIC™ meloxicam, or placebo. The two co-primary
endpoints of the trial were the proportion of patients who are free
from headache pain two hours after dosing, and the proportion of
patients who no longer suffered from their most bothersome
migraine-associated symptom (nausea, photophobia, or phonophobia)
two hours after dosing, for AXS-07 as compared to placebo.
Superiority of AXS-07 to the rizatriptan and MoSEIC™ meloxicam arms
(component contribution) was to be established based on sustained
freedom from headache pain from two to 24 hours after dosing (key
secondary endpoint). The MOMENTUM study was conducted pursuant to
an FDA Special Protocol Assessment (SPA).
About
Migraine
Over 37 million Americans suffer from migraine
according to the Centers for Disease Control, and it is the leading
cause of disability among neurological disorders in the United
States according to the American Migraine Foundation. Migraine is
characterized by recurrent attacks of pulsating, often severe and
disabling head pain associated with nausea, and sensitivity to
light and or sound. It is estimated that migraine accounts for $78
billion in direct (e.g. doctor visits, medications) and indirect
(e.g. missed work, lost productivity) costs each year in the United
States [4]. Published surveys of migraine sufferers indicate that
more than 70% are not fully satisfied with their current treatment,
that nearly 80% would try a new therapy, and that they desire
treatments that work faster, more consistently, and result in less
symptom recurrence [5,6].
About
AXS-07
AXS-07 is a novel, oral, investigational
medicine with distinct dual mechanisms of action under development
for the acute treatment of migraine. AXS-07 consists of MoSEIC™
meloxicam and rizatriptan. Meloxicam is a new molecular entity for
migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced
Inclusion Complex) technology, which results in rapid absorption of
meloxicam while maintaining a long plasma half-life. Meloxicam is a
COX-2 preferential non-steroidal anti-inflammatory drug and
rizatriptan is a 5-HT1B/1D agonist. AXS-07 is designed to
provide rapid, enhanced and consistent relief of migraine, with
reduced symptom recurrence. AXS-07 is covered by more than 44
issued U.S. and international patents which provide protection out
to 2036. AXS-07 is not approved by the FDA.
About Axsome Therapeutics,
Inc.
Axsome Therapeutics, Inc. is a biopharmaceutical
company developing novel therapies for the management of central
nervous system (CNS) disorders for which there are limited
treatment options. For the many people facing unsatisfactory
treatments for CNS disorders, Axsome accelerates the invention and
adoption of life-changing medicines. Axsome’s core CNS product
candidate portfolio includes five clinical-stage candidates,
AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14. AXS-05 is being
developed for major depressive disorder (MDD), treatment resistant
depression (TRD), Alzheimer’s disease (AD) agitation, and as a
treatment for smoking cessation. AXS-07 is being developed for the
acute treatment of migraine. AXS-12 is being developed for the
treatment of narcolepsy. AXS-14 is being developed for
fibromyalgia. AXS-05, AXS-07, AXS-09, AXS-12, and AXS-14 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.
References
- Dodick DW.
Migraine. Lancet. 2018;391(10127):1315-1330.
- Xu H, Han W,
Wang J, Li M. Network meta-analysis of migraine disorder treatment
by NSAIDs and triptans. J Headache Pain. 2016;17(1):113.
- Ferrari MD, Roon
KI, Lipton RB, Goadsby PJ. Oral triptans (serotonin 5-HT(1B/1D)
agonists) in acute migraine treatment: a meta-analysis of 53
trials. Lancet. 2001 Nov 17;358(9294):1668-75.
- Gooch CL, Pracht
E, Borenstein AR. The burden of neurological disease in the
United States: A summary report and call to action. Ann Neurol.
2017 Apr; 81(4):479-484.
- Smelt AF, Louter
MA, Kies DA, Blom JW, Terwindt GM, van der Heijden GJ, De Gucht V,
Ferrari MD, Assendelft WJ. What do patients consider to be the most
important outcomes for effectiveness studies on migraine treatment?
Results of a Delphi study. PLoS One. 2014 Jun 16;9(6):e98933.
- Lipton RB,
Stewart WF. Acute migraine therapy: do doctors understand what
patients with migraine want from therapy? Headache. 1999;39(suppl
2):S20-S26.
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, pace of
enrollment and completion of the trials (including our ability to
fully fund our disclosed clinical trials, which assumes no material
changes to our currently projected expenses), futility analyses and
receipt of interim results, which are not necessarily indicative of
the final results of our ongoing clinical trials, and the number or
type of studies or nature of results necessary to support the
filing of a new drug application (“NDA”) for any of our current
product candidates; 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 U.S. Food and Drug
Administration (“FDA”) or other regulatory authority approval of,
or other action with respect to, our product candidates (including,
but not limited to, with or without a special protocol assessment);
the potential for our clinical trials to provide a basis for
accelerated approval of our product candidates for the treatment of
several indications and accelerate their development timelines and
commercial paths to patients (including, but not limited to, with
or without a breakthrough therapy designation); the Company’s
ability to successfully defend its intellectual property or obtain
the necessary licenses at a cost acceptable to the Company, if at
all; the successful implementation of the Company’s research and
development programs and collaborations; the success of the
Company’s license agreements; the acceptance by the market of the
Company’s product candidates, if approved; the Company’s
anticipated capital requirements, including the Company’s
anticipated cash runway; unforeseen circumstances or other
disruptions to normal business operations arising from or related
to COVID-19; and other factors, including general economic
conditions and regulatory developments, not within the Company’s
control. The factors discussed herein could cause actual results
and developments to be materially different from those expressed in
or implied by such statements. The forward-looking statements are
made only as of the date of this press release and the Company
undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstance.
Axsome Contact: Mark JacobsonChief Operating
OfficerAxsome Therapeutics, Inc.22 Cortlandt Street, 16th FloorNew
York, NY 10007Tel: 212-332-3243Email: mjacobson@axsome.com
www.axsome.com
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