BioXcel Therapeutics Announces Presentations on SERENITY I & II at the 2021 American Psychiatric Association Annual Meeting
April 26 2021 - 7:00AM
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
data from its two pivotal Phase 3 trials (SERENITY I & II) of
BXCL501 for the acute treatment of agitation associated with
schizophrenia and bipolar disorders I and II will be presented at
the upcoming American Psychiatric Association (“APA”) Annual
Meeting. The meeting will be held virtually on May 1-3, 2021.
Poster Presentations:
Title: A Novel Rapidly
Effective Treatment of Agitation for Schizophrenia With the Oral
Dissolving Film BXCL501Presenter: Leslie L.
Citrome, MD, MPH, Clinical Professor of Psychiatry and Behavioral
Sciences at New York Medical College
Title: Novel Rapidly Effective
Treatment of Agitation in Patients with Bipolar Disorders: BXCL501
– An Oral Dissolving Film Presenter: Sheldon H.
Preskorn, MD, Professor, Department of Psychiatry and Behavioral
Sciences at the University of Kansas School of Medicine-Wichita
The posters will be presented within a virtual
poster hall and will be available through the conference portal
from May 1, 2021 to June 1, 2021. The posters will also be
available in the “News & Media” section of the Company’s
website at www.bioxceltherapeutics.com.
About Schizophrenia and Bipolar Disorder
Related Agitation
Agitation is a common and difficult to manage
symptom associated with multiple neuropsychiatric conditions,
including schizophrenia and bipolar disorders I and II. These two
disease states alone have an estimated U.S. prevalence of
approximately 9 million adults with more than 3 million
experiencing agitation each year. On average, patients with these
conditions experience more than a dozen episodes per year, the
majority requiring pharmacologic treatment. Early identification
and prompt intervention to relieve agitation are essential to avoid
symptomatic escalation and the emergence of aggression. Expert
consensus best-practice guidelines have recommended that agitation
should be treated by a combination of behavioral calming
techniques, verbal de-escalation, and medications that are
voluntarily accepted by patients without coercion, with the
pharmacologic goal of “calming without excessive sedation.” A
non-invasive therapy that causes rapid and sustained symptom relief
may be helpful to avoid the costly and traumatic use of coercive
techniques, like physical restraint and seclusion, which may result
in admission and prolonged hospitalization.
About SERENITY I and SERENITY
II
The SERENITY studies were randomized,
double-blinded, placebo-controlled parallel group adaptive trials
in a total of 759 patients, 18 to 75 years of age. SERENITY I
(n=381) enrolled patients with agitation associated with
schizophrenia or schizoaffective disorder, with arms randomized to
receive BXCL501 at 120 micrograms, or 180 micrograms or matching
placebo, respectively. SERENITY II (n=378) enrolled patients with
agitation associated with bipolar disorders, in three treatment
arms randomized to receive BXCL501 at 120 micrograms, 180
micrograms or placebo, respectively. The primary endpoint of the
trials was the reduction in acute agitation measured by the
Positive and Negative Syndrome Scale - Excitatory Component (“PEC”)
change from baseline compared to placebo. The secondary endpoint
was determination of the earliest time where an effect on agitation
is apparent as measured by the change from baseline in PEC total
score.
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
potentially targets a causal agitation mechanism, and the Company
has observed anti-agitation results in multiple clinical studies
across several neuropsychiatric disorders, including schizophrenia
related agitation (SERENITY I), bipolar disorder related agitation
(SERENITY II) and dementia related agitation (TRANQUILITY). BXCL501
has been granted Breakthrough Therapy designation for the acute
treatment of agitation associated with dementia and Fast Track
designation for the acute treatment of agitation associated with
schizophrenia, bipolar disorders and dementia. The Company recently
submitted its New Drug Application to the FDA for BXCL501 for the
acute treatment of agitation associated with schizophrenia and
bipolar disorders. BXCL501 is also currently being evaluated in a
Phase 2 trial (PLACIDITY) for the treatment of agitation associated
with delirium. The safety and efficacy of BXCL501 has not been
established.
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.
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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