Axsome Therapeutics Hosts R&D Day Today with Key Opinion Leaders Focusing on AXS-05 and Unmet Needs in Alzheimer’s Disease Agitation
“We are honored to host two renowned leaders in the field of Alzheimer’s disease agitation research who will discuss the condition and the current treatment landscape” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “Alzheimer’s disease agitation is a serious and distressing condition for which there is currently no approved treatment. We look forward to learning about the potential of AXS-05 in this condition through our ongoing Phase 2/3 ADVANCE-1 trial which has a upcoming interim futility analysis this quarter.”
The R&D day will feature presentations by
A live and archived webcast of the event, with slides, can be accessed on the "Webcasts & Presentations" page of the "Investors" section of the Company's website at www.axsome.com starting at 1:00 PM Eastern Time today.
1:00-1:05: Welcome and Introductions –
1:05-1:15: Axsome Therapeutics CNS Pipeline Overview – Dr.
1:15-1:40: Prevalence and Consequences of Agitation in Alzheimer’s Disease – Dr.
1:40-2:20: Pharmacological Management of Behavioral and Psychological Symptoms in People with Alzheimer’s Disease – Dr.
2:20-2:45: AXS-05: A Potential New Treatment for Agitation in Alzheimer’s Disease – Dr.
2:45-3:00: Panel Discussion and General Q&A
Each KOL presentation will be followed by a Q&A session.
AXS-05 is a novel, oral, investigational medicine consisting of dextromethorphan (an NMDA receptor antagonist, sigma-1 receptor agonist, and serotonin and norepinephrine reuptake inhibitor) and bupropion (a norepinephrine and dopamine reuptake inhibitor, which also increases the bioavailability of dextromethorphan), under development for the treatment of CNS disorders. In addition to the Phase 2/3 trial in agitation associated with AD, AXS-05 is also being evaluated in a Phase 3 trial in treatment resistant depression (TRD), a Phase 2 trial in major depressive disorder, and a Phase 2 trial in smoking cessation. AXS-05 has been granted U.S. Food and Drug Administration Fast Track designations for TRD and for agitation associated with AD.
This event is intended for institutional investors, sell-side analysts, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. The event will be held at the LOTTE New York Palace. To reserve a seat email Kimberly Kenney at firstname.lastname@example.org.
Dr. Cummings originated the Neuropsychiatric Inventory (NPI), and he has published over 700 articles and over 40 books. He is the recipient of numerous awards including the Bengt Winblad Lifetime Achievement Award in Alzheimer’s Research and the
Professor Ballard has held faculty positions at King’s College’s
Author of over 500 articles and investigator on more than 25 clinical trials, Prof. Ballard is an internationally recognized researcher, lecturer, and teacher in psychiatry with subspecialty expertise in geriatric populations and dementia.
About the ADVANCE-1 Study
ADVANCE-1 (Addressing Dementia Via Agitation-Centered Evaluation 1) is a Phase 2/3 multicenter, randomized, double-blind, controlled trial to evaluate the efficacy and safety of AXS-05 in patients with agitation associated with Alzheimer’s disease. Approximately 435 patients will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for 5 weeks. The primary efficacy measure is the Cohen-Mansfield Agitation Inventory (CMAI). The trial incorporates two interim analyses to be performed by an independent data monitoring committee. The first interim analysis will be performed on the first approximately 30% of the target number of subjects to assess futility. The second interim analysis will be performed on the first approximately 60% of the target number of subjects to assess efficacy.
About Alzheimer’s Disease (AD) Agitation
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder that manifests initially as forgetfulness advancing to severe cognitive impairment and memory loss. It afflicts an estimated 5 million individuals in
AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 consists of dextromethorphan and bupropion, and utilizes Axsome’s metabolic inhibition technology. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is an investigational drug product not approved by the
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company 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 the Company’s ongoing clinical trials and anticipated clinical trials for its current product candidates, including statements regarding the timing of initiation, interim analyses and completion of the trials, futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; the Company’s ability to fund additional clinical trials to continue the advancement of its product candidates; the timing of and the Company’s ability to obtain and maintain
Source: Axsome Therapeutics, Inc.