Axsome Therapeutics to Provide Update on Continued Progress at the 2019 Cantor Global Healthcare Conference
GEMINI Phase 3 placebo-controlled trial of AXS-05 in MDD on track for readout of topline results in 4Q 2019
STRIDE-1 Phase 3 trial of AXS-05 in TRD on track for readout of topline results in 4Q 2019
MOMENTUM Phase 3 trial of AXS-07 in migraine on track for readout of topline results in 4Q 2019
CONCERT Phase 2 trial of AXS-12 in narcolepsy on track for readout of topline results in 4Q 2019
Cash runway into 4Q 2021
Dr. Tabuteau will provide the following update on the Company’s continued progress during the presentation:
AXS-05: AXS-05 (dextromethorphan/bupropion modulated delivery tablet) is Axsome’s novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the following indications: treatment resistant depression (TRD), major depressive disorder (MDD), Alzheimer’s disease (AD) agitation, and smoking cessation. AXS-05 has been granted
- To date, approximately 75% of the targeted number of patients have been randomized into the GEMINI Phase 3 placebo-controlled trial of AXS-05 in MDD. Axsome remains on track to report topline efficacy results from both the GEMINI trial and the STRIDE-1 trial of AXS-05 in TRD in the fourth quarter of 2019.
- An NDA filing for AXS-05 in the treatment of MDD is targeted for the second half of 2020.
Alzheimer’s Disease Agitation
- To date, approximately 65% of the targeted number of patients have been randomized into the ADVANCE-1 Phase 2/3 trial of AXS-05 in agitation associated with Alzheimer’s disease. Axsome continues to anticipate topline results from the ADVANCE-1 trial in the first half of 2020.
AXS-07: AXS-07 (MoSEIC™ meloxicam/rizatriptan) is Axsome’s novel, oral, investigational medicine with distinct dual mechanisms of action being developed for the acute treatment of migraine.
- To date, more than 80% of the targeted number of patients have been randomized into the MOMENTUM Phase 3 trial of AXS-07 in the acute treatment of migraine. MOMENTUM is being conducted pursuant to an FDA Special Protocol Assessment (SPA). Axsome remains on track to report topline results from the MOMENTUM trial in the fourth quarter of 2019.
- An NDA filing for AXS-07 in the acute treatment of migraine is targeted for the second half of 2020.
AXS-12: AXS-12 (reboxetine) is Axsome’s novel, oral, potent and highly selective norepinephrine reuptake inhibitor being developed for the treatment of narcolepsy. AXS-12 has been granted Orphan Drug Designation by the
- To date, 70% of the targeted number of patients have been randomized into the CONCERT Phase 2 trial of AXS-12 in patients with narcolepsy. Axsome remains on track to report topline results from the CONCERT trial in the fourth quarter of 2019.
- Axsome believes that its current cash will be sufficient to fund the Company’s anticipated operations, based on its current operating plans, into the fourth quarter of 2021, well beyond the readout of all of the above ongoing clinical trials.
- As previously disclosed, Axsome currently does not anticipate future equity financings prior to the readout from its Phase 3 trials.
A live webcast and archive of the event can be viewed on the "Webcasts & Presentations" page of the "Investors" section of the Company's website at www.axsome.com.
AXS-05 is a novel, oral, patent-protected, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of major depressive disorder and other central nervous system (CNS) disorders. AXS-05 consists of a proprietary formulation and dose of dextromethorphan and bupropion and utilizes Axsome’s metabolic inhibition technology. The dextromethorphan component of AXS-05 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, which is a novel mechanism of action, meaning it works differently than currently approved therapies for major depressive disorder. The dextromethorphan component of AXS-05 is also a sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is covered by more than 36 issued U.S. and international patents which provide protection out to 2034. AXS-05 is not approved by 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 (
AXS-12 (reboxetine) is a novel, oral, investigational medicine in development for the treatment of the symptoms of narcolepsy. AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor. AXS-12 is an investigational drug product not approved by the
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.