BioXcel Therapeutics to Host Virtual Key Opinion Leader Event to Highlight BXCL501 as a Potential Treatment for Agitation and...
12 February 2021 - 11:00PM
BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (Nasdaq:
BTAI), a clinical-stage biopharmaceutical company utilizing
artificial intelligence approaches to develop transformative
medicines in neuroscience and immuno-oncology, today announced that
the Company will host a virtual Key Opinion Leader (“KOL”) event on
Friday, February 19, 2021 from 11:00 am ET to 2:00 pm ET. The event
aims to highlight BXCL501, the Company’s investigational,
proprietary, orally dissolving thin film formulation of
dexmedetomidine (“Dex”), and its potential as a treatment option
for multiple neuropsychiatric conditions.
BioXcel’s management team will be joined by leading experts for
each indication to discuss the significant unmet medical need and
BXCL501’s potential to change the treatment paradigm.
KOL Presenters Include:
Schizophrenia/Bipolar Related Agitation
- Scott Zeller, MD, is an Assistant Clinical Professor of
Psychiatry at the University of California-Riverside and Touro
University medical schools. He served as Chief of Psychiatric
Emergency Services of the Alameda Health System for twenty years,
as well as founded Project BETA, which revolutionized the care
approach for agitated individuals worldwide; he has also authored
several books and numerous research articles on Agitation. Dr.
Zeller is the Past President of the American Association for
Emergency Psychiatry and Past Chair of the multidisciplinary
National Coalition on Psychiatric Emergencies.
Dementia Related Agitation
- Alan Breier, MD, is a Mental Health Research and Education
Senior Professor of Psychiatry at Indiana University School of
Medicine. Additionally, at the University, he is Vice-Chair for
Clinical Research, the Chief of IU Psychotic Disorders Program, and
the Director of the Prevention and Recovery Center for Early
Psychosis. Previously, he served as the Chief Medical Officer and
Vice President of Pharmaceutical Products at Eli Lilly, where he
was also the product team leader for the antipsychotic drug
Zyprexa®.
- Larry Ereshefsky, PharmD, FCCP, BCPP, is a founding member of
the International Society for CNS Clinical Trials and Methodology,
serving as Chair of the Behavioral and Psychological Symptoms of
Dementia Steering Committee and Co-Chaired the Agitation and Apathy
sub-groups. He is a retired Regents Professor of Pharmacy,
Psychiatry, and Pharmacology at the University of Texas/UT Health
Science Center and has designed and conducted more than 80 CNS
clinical trials evaluating treatments for Alzheimer’s and other
neurodegenerative disorders, contributing to several drug approvals
spanning neurology and psychiatry. He serves as the Chief
Scientific Officer for APEX Innovative Sciences and for Follow the
Molecule LLC, where he focuses on translational drug development
strategies.
Opioid Withdrawal Symptoms
- Thomas R. Kosten, MD, is the JH Waggoner Chair and Professor of
Psychiatry, Pharmacology, Immunology, Pathology, and Neuroscience
of the Dan Duncan Institute for Clinical and Translational Research
at Baylor College of Medicine. He has directed a national NIDA
Medications Development Center since 1988, was previously the
Research Director of the VA National Substance Use Disorders
Quality Enhancement Research Initiative at the Michael E. DeBakey
VA Medical Center and is the founder of the Division of Substance
Abuse at Baylor College of Medicine and at Yale University School
of Medicine.
Delirium Related Agitation
- E. Wesley Ely, MD, MPH, is a subspecialist in Pulmonary and
Critical Care Medicine who conducts health services research as a
Professor of Medicine in the Division of Allergy, Pulmonary, and
Critical Care Medicine at Vanderbilt University Medical Center. He
is a practicing intensivist with a focus on Geriatric ICU Care, as
the Associate Director for Research for the VA Tennessee Valley
Geriatric Research and Education Clinical Center. Dr. Ely is also
the co-director of the Center for Critical Illness, Brain
Dysfunction, and Survivorship, where his team developed the primary
tool used to measure delirium clinically and in ICU-based
trials.
A live webcast of the event will be accessible through the
Investors section of the Company’s website at
www.bioxceltherapeutics.com on February 19th at 11:00 am ET.
Following the event, the webcast will be archived on the Company’s
website for at least 30 days.
About BXCL501
BXCL501 is an investigational, proprietary, orally dissolving
thin film formulation of dexmedetomidine, a selective alpha-2a
receptor agonist for the treatment of agitation and opioid
withdrawal symptoms. BioXcel believes that BXCL501 directly targets
a causal agitation mechanism, and the Company has observed
anti-agitation results in multiple clinical studies across several
neuropsychiatric disorders. BXCL501 has been granted Fast Track
Designation by the U.S. Food and Drug Administration for the acute
treatment of agitation in patients with schizophrenia, bipolar
disorders, and dementia. BXCL501 has been studied in two Phase 3
trials (SERENITY I and II) for the acute treatment of schizophrenia
related agitation and bipolar disorder related agitation,
respectively, and in a Phase 1b/2 trial (TRANQUILITY) for the acute
treatment of dementia related agitation. This product candidate is
also currently being evaluated in a Phase 1b/2 study (RELEASE) for
the treatment of opioid withdrawal symptoms, with plans to initiate
a Phase 2 trial in hospitalized patients suffering from delirium
related agitation within the next several months.
BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. is a clinical stage biopharmaceutical
company utilizing artificial intelligence approaches to develop
transformative medicines in neuroscience and immuno-oncology.
BioXcel’s drug re-innovation approach leverages existing approved
drugs and/or clinically validated product candidates together with
big data and proprietary machine learning algorithms to identify
new therapeutic indices. BioXcel’s two most advanced clinical
development programs are BXCL501, an investigational, proprietary,
orally dissolving thin film formulation of dexmedetomidine for the
treatment of agitation and opioid withdrawal symptoms, and BXCL701,
an investigational, orally administered, systemic innate immunity
activator in development for the treatment of aggressive forms of
prostate cancer and advanced solid tumors that are refractory or
treatment naïve to checkpoint inhibitors. For more information,
please visit www.bioxceltherapeutics.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements in this press release include but
are not limited to BXCL501’s potential as a treatment option for
multiple neuropsychiatric conditions. When used herein, words
including “anticipate,” “being,” “will,” “plan,” “may,” “continue,”
and similar expressions are intended to identify forward-looking
statements. In addition, any statements or information that refer
to expectations, beliefs, plans, projections, objectives,
performance, or other characterizations of future events or
circumstances, including any underlying assumptions, are
forward-looking. All forward-looking statements are based upon
BioXcel’s current expectations and various assumptions. BioXcel
believes there is a reasonable basis for its expectations and
beliefs, but they are inherently uncertain.
BioXcel may not realize its expectations, and its beliefs may
not prove correct. Actual results could differ materially from
those described or implied by such forward-looking statements as a
result of various important factors, including, without limitation,
its limited operating history; its incurrence of significant
losses; its need for substantial additional funding and ability to
raise capital when needed; its limited experience in drug discovery
and drug development; its dependence on the success and
commercialization of BXCL501 and BXCL701 and other product
candidates; the failure of preliminary data from its clinical
studies to predict final study results; failure of its early
clinical studies or preclinical studies to predict future clinical
studies; its ability to receive regulatory approval for its product
candidates; its ability to enroll patients in its clinical trials;
undesirable side effects caused by BioXcel’s product candidates;
its approach to the discovery and development of product candidates
based on EvolverAI is novel and unproven; its exposure to patent
infringement lawsuits; its ability to comply with the extensive
regulations applicable to it; impacts from the COVID-19 pandemic;
its ability to commercialize its product candidates; and the other
important factors discussed under the caption “Risk Factors” in its
Quarterly Report on Form 10-Q for the quarterly period ended
September 30, 2020, as such factors may be updated from time to
time in its other filings with the SEC, which are accessible on the
SEC’s website at www.sec.gov and the Investors section of our
website at www.bioxceltherapeutics.com.
These and other important factors could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management’s estimates as of the date of this
press release. While BioXcel may elect to update such
forward-looking statements at some point in the future, except as
required by law, it disclaims any obligation to do so, even if
subsequent events cause our views to change. These forward-looking
statements should not be relied upon as representing BioXcel’s
views as of any date subsequent to the date of this press
release.
Contact Information:
BioXcel Therapeutics, Inc.
www.bioxceltherapeutics.com
Investor Relations:
Mary ColemanBioXcel Therapeutics, VP of Investment
RelationsMColeman@bioxceltherapeutics.com1.475.238.6837
John GrazianoSolebury
Troutjgraziano@soleburytrout.com1.646.378.2942
Media:
Julia DeutschSolebury
Troutjdeutsch@soleburytrout.com1.646.378.2967
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