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 U.S. Food and Drug Administration (“FDA”) has accepted for
filing the New Drug Application (“NDA”) for BXCL501, the Company’s
proprietary, investigational, orally dissolving thin film
formulation of dexmedetomidine, for the acute treatment of
agitation associated with schizophrenia and bipolar disorders I and
II. The FDA has assigned a Prescription Drug User Fee Act (“PDUFA”)
target action date of January 5, 2022. At this time, the FDA is not
planning to hold an advisory committee meeting to discuss the
application.
“The filing of our NDA marks an important milestone toward our
goal to provide a new treatment option for the millions of patients
with schizophrenia and bipolar disorders struggling with acute
agitation,” said Vimal Mehta, Chief Executive Officer of BioXcel.
“We believe that BXCL501, if approved, would represent a
significant improvement in the care and management of agitation in
these patients, potentially easing the burden for physicians and
allied caregivers. While the FDA reviews our application, we will
continue to execute on our comprehensive commercial strategy to
ensure we are well positioned for potentially bringing BXCL501 –
which is designed to address an important unmet need – to both
patients and health care providers across the U.S.”
The application is supported by data from two randomized,
double-blinded, placebo-controlled, parallel group Phase 3 studies
(SERENITY I & SERENITY II) of BXCL501 for the
acute treatment of agitation associated with schizophrenia and
bipolar disorders I and II, respectively. In both trials, BXCL501
was well-tolerated and met the primary and secondary endpoints at
the 120 mcg and 180 mcg doses, demonstrating statistically
significant, rapid and durable improvements from baseline versus
placebo across multiple agitation scales.
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 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
received acceptance of its New Drug Application for BXCL501 for the
acute treatment of agitation associated with schizophrenia and
bipolar disorders. 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.
Forward-Looking StatementsThis 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 the
timing of FDA’s review of BioXcel’s NDA submission, the potential
commercialization of BXCL501 and BXCL501’s ability to treat those
suffering from agitation associated with schizophrenia and bipolar
disorders I and II. 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.
These forward-looking statements are based on management’s
current expectations and beliefs. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause BioXcel’s
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements, including,
but not limited to, the following: 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 March 31, 2021, 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 Investors
sections 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 its 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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