NEW YORK, March 27, 2018 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a clinical-stage
biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced
that it will host a research and development (R&D) day with key opinion leaders (KOLs), highlighting the company’s CNS product
candidate AXS-05, and unmet needs in depression, agitation associated with Alzheimer’s disease, and nicotine dependence, on
Tuesday, April 24, 2018 in New York City.
The event will feature presentations by Maurizio Fava, MD (Massachusetts General Hospital), Marc Agronin, MD
(University of Miami), and James Davis, MD (Duke University), who will discuss the current treatment landscape and unmet medical
needs for patients with treatment resistant depression, agitation associated with Alzheimer’s disease, and nicotine dependence,
respectively; and a presentation by Stephen Stahl, MD, PhD, DSc (University of California, San Diego) who will discuss the unique
pharmacology of AXS-05 (bupropion and dextromethorphan) and its relevance to these conditions. The presenters will be available to
answer questions following their presentations.
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.
KOL Presenters:
- Stephen M. Stahl, MD, PhD, DSc (Hon). Adjunct Professor of Psychiatry, University of California San Diego;
Honorary Visiting Senior Fellow, University of Cambridge, UK; Chairman, Neuroscience Education Institute; Chairman, Arbor
Scientia Group; Editor-in Chief, CNS Spectrums; and Director of Psychopharmacology Services and Senior Academic Advisor,
California Department of State Hospitals
- Maurizio Fava, MD. Director, Division of Clinical Research of the Massachusetts General
Hospital (MGH) Research Institute; Executive Vice Chair of the Department of Psychiatry and Executive Director of the Clinical
Trials Network and Institute (MGH); and Associate Dean for Clinical and Translational Research and the Slater Family Professor of
Psychiatry at Harvard Medical School
- Marc Agronin, MD. Vice President of Behavioral Health and Clinical Research at Miami Jewish Health; and
Affiliate Associate Professor of Psychiatry and Neurology at University of Miami Miller School of Medicine
- James Davis, MD. Medical Director of the Duke Center for Smoking Cessation; Director of the Duke Smoking
Cessation Program; Co-Director of the Duke-UNC Tobacco Treatment Specialist Training Program; and Associate Professor of
Medicine, Duke University School of Medicine
AXS-05 is a novel glutamatergic and monaminergic product candidate under development for the treatment of CNS
disorders. It is currently being evaluated in the STRIDE-1 Phase 3 trial in treatment resistant depression and the ADVANCE-1 Phase
2/3 trial in agitation associated with Alzheimer’s disease. A Phase 2 trial of AXS-05 in smoking cessation is planned. AXS-05 has
been granted U.S. Food and Drug Administration Fast Track designations for treatment resistant depression and for agitation
associated with Alzheimer’s disease.
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 Kimberly Kenney at
kkenney@axsome.com.
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.
KOL Credentials
- Stephen M. Stahl, MD, PhD, DSc (Hon)
Dr. Stahl has held faculty positions at Stanford University, the University of California at Los Angeles, the
Institute of Psychiatry London, the Institute of Neurology London, and, currently, as professor at the University of California
at San Diego and as Honorary Fellow in Psychiatry at the University of Cambridge. Dr. Stahl serves as editor-in-chief of CNS
Spectrums journal.
Author of over 500 articles and chapters, and more than 1,600 scientific presentations and abstracts, Dr. Stahl is an
internationally recognized clinician, researcher, and teacher in psychiatry with subspecialty expertise in psychopharmacology.
Dr. Stahl has written 39 textbooks and edited 13 others, including the best-selling and award-winning textbook, Stahl’s Essential
Psychopharmacology, and clinical manual, Essential Psychopharmacology Prescriber’s Guide. Dr. Stahl is Senior Academic Advisor
and Director of Psychopharmacology for the California Department of State Hospitals (DSH) where he has a leadership role in
addressing violence in the five-hospital, 6,500 patient DSH. He has been awarded the International College of
Neuropsychopharmacology Lundbeck Foundation Award in Education for his contributions to postgraduate education in psychiatry and
neurology. His books have won the British Medical Association’s Book of the Year Award. Dr. Stahl is the recipient of numerous
scientific and clinical awards and honors.
- Maurizio Fava, MD
Dr. Maurizio Fava is the Director of the Clinical Research Program, Executive Vice Chair of the Department of
Psychiatry, and Executive Director of the Clinical Trials Network and Institute, at Massachusetts General Hospital. Dr. Fava is
also the Slater Family Professor of Psychiatry, and Associate Dean for Clinical and Translational Research, at Harvard Medical
School.
Dr. Fava is a world leader in the field of depression. He has edited eight books and authored or co-authored more than 900
original articles published in medical journals with international circulation, articles which have been cited more than 60,000
times in the literature and with an h index of over 120. Dr. Fava obtained his medical degree from the University of Padova
School of Medicine and completed residency training in endocrinology at the same university. He then moved to the United States
and completed residency training in psychiatry at MGH. He founded and was director of the hospital’s Depression Clinical and
Research Program from 1990 until 2014. In 2007, he also founded and is now the executive director of the MGH Psychiatry Clinical
Trials Network and Institute, the first academic CRO specialized in the coordination of multi-center clinical trials in
psychiatry. Dr. Fava’s prominence in the field is reflected in his role as the co-principal investigator of STAR*D, the largest
research study ever conducted in the area of depression, and of the RAPID Network, the NIMH-funded series of studies of novel,
rapidly-acting antidepressant therapies. Dr. Fava has received several awards during his career and is on the editorial board of
five international medical journals.
- Marc Agronin, MD
Dr. Marc Agronin is the Vice President of Behavioral Health and Clinical Research at Miami Jewish Health (MJH), and
Affiliate Associate Professor of Psychiatry and Neurology at University of Miami Miller School of Medicine.
Dr. Agronin is an award-winning geriatric psychiatrist and a national expert in the field of Alzheimer’s research and
intervention. Dr. Agronin is the founding and current director of the Mental Health and Memory Center and Alzheimer’s clinical
research program at MJH, Florida’s largest not-for-profit long-term care provider. The center provides evaluation and treatment
of memory disorders, mood and associated behavior problems, and conducts research trials in these conditions. He is a graduate of
Harvard University, summa cum laude, and the Yale School of Medicine. Dr. Agronin trained in psychiatry at Harvard Medical School
and later completed a fellowship in geriatric psychiatry at the VA Medical Center in Minneapolis, MN. He has authored numerous
books and scientific articles, including “Alzheimer’s Disease and Other Dementias, A Practical Guide, 3rd Edition,” the
acclaimed “How We Age: A Doctor’s Journey into the Heart of Growing Old,” and its sequel “The End of Old Age: Living a
Longer, More Purposeful Life”. Dr. Agronin currently writes a regular blog for the Experts panel of the Wall Street Journal
and lectures extensively around the country, including annual presentations at the U. S. Psychiatric Congress.
- James Davis, MD
Dr. James Davis is the Medical Director of the Duke Center for Smoking Cessation, Director of the Duke Smoking
Cessation Program, Co-Director of the Duke-UNC Tobacco Treatment Specialist Training Program, and Associate Professor of Medicine
at Duke University School of Medicine.
Dr. Davis is an investigator on 23 clinical trials funded through the National Institutes on Drug Abuse, National Cancer
Institute, and the American Lung Association. His main area of research is development and testing of tobacco dependence
treatments and is currently investigating new pharmacotherapies, adaptive medication regimens, telemedicine, and integration of
therapeutic technologies. At Duke Center for Smoking Cessation, Dr. Davis works closely with Dr. Jed Rose, co-developer of the
nicotine patch and other nationally acclaimed leaders in animal and neurobehavioral tobacco treatment research. Investigators in
this group collectively claim over 500 tobacco treatment publications in the last decade. Additionally, Dr. Davis oversees a
network of specialized tobacco treatment clinics providing services within Duke Cancer Institute, Duke Primary Care, Duke
Perioperative Medicine, Duke Infectious Disease, Duke Pulmonology, and Duke Hospitals and Hospital-Based Clinics. As co-director
of the Duke-UNC Tobacco Treatment Specialist Training Program, Dr. Davis co-authors a 350-page authoritative training manual on
tobacco dependence. This program provides a nationally recognized credential with regular training to medical providers across
the Southeastern US. Finally, Dr. Davis was committee chair for development of National Comprehensive Cancer Network 2017
Tobacco Treatment Guideline and serves as an advisor to the North Carolina General Assembly Tobacco Treatment Taskforce and North
Carolina Tobacco Prevention and Control Branch.
About AXS-05
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.
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 product candidate
portfolio includes five clinical-stage candidates, AXS-02, AXS-05, AXS-06, AXS-07, and AXS-09. AXS-05 is currently in a Phase 3
trial in treatment resistant depression (TRD) and a Phase 2/3 trial in agitation associated with Alzheimer’s disease (AD). AXS-05
is also being developed for smoking cessation. AXS-02 is currently in a Phase 3 trial in knee osteoarthritis (OA) associated with
bone marrow lesions (BMLs) with an additional Phase 3 trial planned in chronic low back pain (CLBP) associated with Modic changes
(MCs). AXS-07 is being developed for the acute treatment of migraine. AXS-06 is being developed for the treatment of osteoarthritis
and rheumatoid arthritis and for the reduction of the risk of NSAID-associated gastric ulcers. AXS-02, AXS-05, AXS-06, AXS-07, and
AXS-09 are investigational drug products not approved by the FDA. For more information, please visit the company website at
www.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”. 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 U.S. Food and Drug Administration or other regulatory authority approval
of, or other action with respect to, its product candidates; 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; 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.
25 Broadway, 9th Floor
New York, NY 10004
Tel: 212-332-3243
Email: mjacobson@axsome.com
www.axsome.com
