Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the
management of central nervous system (CNS) disorders, will present
positive results from a Phase 1 pharmacokinetic trial of AXS-07
(MoSEIC™ meloxicam and rizatriptan) at the 19th Congress of the
International Headache Society (IHC) in Dublin on September 6,
2019. AXS-07 is Axsome’s novel, oral, investigational medicine with
distinct dual mechanisms of action being developed for the acute
treatment of migraine. Results of the Phase 1 trial
demonstrated that AXS-07 is rapidly absorbed after oral
administration, with the MoSEIC meloxicam component also displaying
an extended plasma half-life, suggesting the potential for enhanced
and sustained efficacy. These results support the ongoing MOMENTUM
(Maximizing Outcomes in Treating Acute Migraine) Phase 3 trial of
AXS-07 in migraine patients with a history of inadequate response
to prior acute treatments.
The Phase 1 trial examined the pharmacokinetics
of AXS-07 tablets (20 mg MoSEIC meloxicam/10 mg rizatriptan), and
10 mg standard rizatriptan in healthy volunteers. After oral
administration of AXS-07, therapeutic plasma concentrations of
MoSEIC meloxicam were attained in a median time of 17 minutes, the
trial’s pre-specified primary endpoint, while maximum plasma
concentrations of the rizatriptan component were reached in a
median time of 38 minutes. These results suggest the potential for
enhanced onset of action for AXS-07. In addition, the terminal
half-life of MoSEIC meloxicam was 18 hours indicating the potential
for sustained effect. With the administration of AXS-07, the
absorption of rizatriptan was numerically faster, and the resulting
plasma concentrations numerically greater, as compared to standard
rizatriptan. AXS-07 was well tolerated with no relevant differences
in safety profile across the two treatment arms. There were no
serious adverse events in the study.
The efficacy of AXS-07 in the acute treatment of
migraine is currently being evaluated in the ongoing MOMENTUM Phase
3 trial, in which patients are randomized to treatment with AXS-07,
rizatriptan, MoSEIC meloxicam, or placebo. MOMENTUM is
enrolling only patients with a history of inadequate response to
prior acute treatments, assessed using the Migraine Treatment
Optimization Questionnaire (mTOQ-4), and the majority of patients
randomized to date also report associated allodynia (pain from a
normally non-painful stimulus), reflecting a more
treatment-resistant population.
The presentation at the IHC includes the Phase 1
trial results as well as information on the design and targeted
patient population of the ongoing MOMENTUM Phase 3 trial. Below are
the details of the poster presentation:
Title: AXS-07
(MoSEIC™ Meloxicam/Rizatriptan): Novel Oral Therapeutic in
Clinical Development for the Acute Treatment of Migraine
Poster Number: IHC-PO-124
Date and Time: Friday, September 6, 2019,
11AM-12PM IST.
A copy of the poster presentation is available
on the “Publications” page of the “Science” section of Axsome’s
website at www.axsome.com.
Phase 1 Trial Design
The study was a randomized, parallel group trial
to evaluate the pharmacokinetics and safety of AXS-07 tablets (20
mg MoSEIC™ meloxicam/10 mg rizatriptan), and 10 mg standard
rizatriptan, after single-dose, oral administration in healthy
volunteers. A total of 20 healthy volunteers were randomly assigned
in a 1:1 ratio to treatment with AXS-07 or standard rizatriptan,
under fasting conditions. The primary endpoint was the time to
therapeutic concentration of meloxicam.
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/D agonist. AXS-07 is designed to
provide rapid, enhanced and consistent relief of migraine, with
reduced symptom recurrence. AXS-07 is 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
3 trial in major depressive disorder (MDD), and a Phase 2/3 trial
in agitation associated with Alzheimer’s disease (AD). AXS-05 is
also being developed for smoking cessation treatment. AXS-07 is
currently in a Phase 3 trial for the acute treatment of migraine.
AXS-12 is currently in a Phase 2 trial in narcolepsy. AXS-05,
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.
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, FDA’s agreement with the Company’s
plan to discontinue the bupropion treatment arm of the ADVANCE-1
study in accordance with the independent data monitoring
committee’s recommendations); the potential for the ASCEND clinical
trial to provide a basis for approval of AXS-05 for the treatment
of major depressive disorder and accelerate its development
timeline and commercial path to patients; 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 and the Company’s current expectations
regarding its plans for future equity financings prior to the
readout from its Phase 3 trials; 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 Jacobson Senior Vice
President, Operations Axsome Therapeutics, Inc. 200 Broadway, 3rd
Floor New York, NY 10038 Tel: 212-332-3243 Email:
mjacobson@axsome.com www.axsome.com
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