Axsome Therapeutics to Host R&D Day with Key Opinion Leaders Focused on AXS-05 and Unmet Needs in Alzheimer’s Disease Agitation
The event will feature presentations from
The Axsome executive management team will also provide an update on the ongoing clinical development of AXS-05 as well as on the rest of the Company’s CNS pipeline.
Jeffrey Cummings, MD, ScD. Director of the Center for Neurodegeneration and Translational Neuroscience; Director Emeritus, Cleveland Clinic Lou Ruvo Center for Brain Health; and Professor of Neurology, at the Cleveland Clinic Lerner College of Medicine
Clive Ballard, MD, MRCPsych, MSc. Pro-Vice Chancellor and Executive Dean of Medicine, University of Exeter
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
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. To reserve a seat email
A live and archived webcast of the event, with slides, can be accessed on the investor page of Axsome’s website at www.axsome.com.
Jeffrey Cummings, MD, ScD
Jeffrey Cummingsis the Director of the Center for Neurodegeneration and Translational Neuroscienceand Director Emeritus of the Lou Ruvo Center for Brain Healthat the Cleveland Clinic Neurological Institute. He holds a faculty position as Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. He has previously held numerous faculty and directorship positions at the UCLAschool of Medicine, Boston University School of Medicine, University of Nevada College of Liberal Arts, University of Nevada Las Vegas School of Medicine, and the Department of Veterans Affairs. He is past President of the Behavioral Neurology Societyand of the American Neuropsychiatric Association. Dr. Cummingsoriginated 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 Ronald and Nancy Reagan ResearchAward from the national Alzheimer’s Association. Clive Ballard, MD, MSc Professor Ballardhas held faculty positions at King’s College’s Institute of Psychiatryas Professor of Age-Related Diseases, Co-Director of the Biomedical Research Unit for Dementia, and Co-Director of the Wolfson Center for Age-Related Disease; University of Newcastleas Professor of Old Age Psychiatry; University of Birminghamas a Lecturer in Psychiatry; and, currently, as Pro-Vice Chancellor and Executive Dean of Medicine at the University of Exeter. He has also served as Director of Research for the Alzheimer’s Society.
Author of over 500 articles and investigator on more than 25 clinical trials,
Prof. Ballardis 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 bupropion and dextromethorphan 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 FDA.
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; the timing of and the Company’s ability to obtain and maintain
Source: Axsome Therapeutics, Inc.