Axsome Therapeutics Announces Continued Progress in Clinical Development of AXS-07 for the Acute Treatment of Migraine
Enrollment in MOMENTUM Phase 3 migraine trial of AXS-07 in patients with history of inadequate response nearly complete; on track for topline results in 4Q 2019
First patient dosed in new INTERCEPT Phase 3 migraine trial evaluating early treatment with AXS-07; topline results anticipated in 1Q 2020
MINDSET survey of migraine specialists supports rationale for MOMENTUM and INTERCEPT trials of AXS-07
Migraine key opinion leaders conference call planned for
“We are pleased with the continued progress in the clinical development of AXS-07 for the acute treatment of migraine. With a potential NDA filing for AXS-07 next year, the newly launched INTERCEPT early treatment trial is designed to further enhance the positioning of AXS-07 and ready it for potential market entry,” said
The Company plans to hold an investor R&D call with migraine key opinion leaders on
AXS-07 Progress Update
MOMENTUM Phase 3 Trial in Patients with History of Inadequate Response
- Enrollment in the MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) trial is nearly complete, and the Company remains on track to report topline results from this study in the fourth quarter of 2019.
- MOMENTUM is enrolling only patients with a history of inadequate response to prior acute migraine treatments, assessed using the Migraine Treatment Optimization Questionnaire (mTOQ-4), and incorporates the potent active comparator rizatriptan. The trial is being conducted pursuant to an FDA Special Protocol Assessment (SPA). Based on
FDAfeedback, this trial, if positive, will be the only efficacy trial required to support an NDA filing for AXS-07 for the acute treatment of migraine.
INTERCEPT Phase 3 Trial Evaluating Early Treatment of Migraine Pain
- The Company launched the INTERCEPT (Initiating Early Control of Migraine Pain and Associated Symptoms) trial, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the early treatment of migraine with AXS-07.
- In contrast to the ongoing MOMENTUM trial in which patients with a history of inadequate response treat migraine attacks once they have become of moderate or severe intensity, in the INTERCEPT trial, patients are to administer AXS-07 at the earliest sign of migraine pain. Approximately 300 patients will be randomized in this study in a 1:1 ratio to treatment with AXS-07 or placebo. Topline results from the INTERCEPT trial are anticipated in the first quarter of 2020.
- Axsome separately announced today results of the “Migraine Treatment Needs and Physician Receptivity” (MINDSET) survey of 106 neurologists and other migraine-treating physicians, who collectively treat more than 50,000 migraine patients annually. The MINDSET survey was conducted to understand treating physicians’ views of the unmet needs in the acute treatment of migraine and their potential receptivity to AXS-07.
- The vast majority of physicians cite efficacy as the most significant unmet need in the acute treatment of migraine, and believe it is very important for patients to administer their acute treatment at the earliest sign of migraine pain (85% and 90% of physicians, respectively).
- If AXS-07 demonstrates superior efficacy over rizatriptan as assessed in the ongoing MOMENTUM trial, 91% of physicians report that they are more likely to prescribe AXS-07 over currently available treatments, with 56% reporting that they are significantly or moderately more likely to prescribe AXS-07.
- If AXS-07 demonstrates superior efficacy over rizatriptan as assessed in the ongoing MOMENTUM trial, 87% of physicians report that they are more likely to prescribe AXS-07 over other drugs in development, including oral CGRPs, that have not demonstrated superior efficacy to current treatments, with 56% reporting that they are significantly or moderately more likely to prescribe AXS-07.
Migraine Key Opinion Leaders (KOLs) Conference Call
- Axsome plans to host an investor R&D conference call and webcast on
November 25, 2019with migraine key opinion leaders (KOLs), focusing on AXS-07 and the unmet needs in the acute treatment of migraine.
- This R&D event will feature presentations from Dr.
Stewart J. Tepper, Professor of Neurology at The Geisel School of Medicineat Dartmouth, and from Dr. Richard B. Lipton, Professor and Vice Chair of Neurology, and Director of the Montefiore Headache Center, at the Albert Einstein College of Medicine. Additional event details including the agenda and access information will be provided at a later date.
About the INTERCEPT Trial Evaluating Early Treatment
INTERCEPT (Initiating Early Control of Migraine Pain and Associated Symptoms) is a Phase 3, randomized, double-blind, multicenter, placebo-controlled trial evaluating the early treatment of migraine with AXS-07. Approximately 300 patients will be randomized in a 1:1 ratio to treatment with AXS-07 or placebo. Patients are to administer AXS-07 at the earliest sign of migraine pain. The two co-primary endpoints of the trial are the proportion of patients who are free from headache pain two hours after dosing, and the proportion of patients who no longer suffer from their most bothersome migraine-associated symptom (nausea, photophobia, or phonophobia) two hours after dosing.
About the MOMENTUM Trial in Patients with History of Inadequate Response
MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) is 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 in patients with a history of inadequate response to prior acute treatments. Approximately 875 eligible patients will be 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 are the proportion of patients who are free from headache pain two hours after dosing, and the proportion of patients who no longer suffer 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 meloxicam arms (component contribution) will be established based on sustained freedom from headache pain from two to 24 hours after dosing. The MOMENTUM study is being conducted pursuant to an FDA Special Protocol Assessment (SPA).
Over 37 million Americans suffer from migraine according to the
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 (
- 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
Source: Axsome Therapeutics, Inc.