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 has completed the rolling submission of its New Drug
Application (“NDA”) to the U.S. Food and Drug Administration
(“FDA”) for BXCL501 for the acute treatment of agitation associated
with schizophrenia and bipolar disorders I and II. BXCL501 is the
Company’s proprietary, investigational, orally dissolving thin film
formulation of dexmedetomidine (“Dex”). The FDA has a 60-day filing
review period to determine whether the NDA is complete and
acceptable for filing.
“This submission is a significant achievement for BioXcel,
having taken this program from its first-in-human trial to NDA
submission in just over 2 years,” commented Vimal Mehta, Chief
Executive Officer of BioXcel. “BXCL501 was discovered using our
innovative AI platform and we believe, if approved, could provide
health professionals and patients with a fast acting, orally
dissolving treatment option. We look forward to hearing back from
the FDA and continuing with our commercial preparations to
potentially bring a novel product that is designed to treat
agitation associated with schizophrenia and bipolar disorders I and
II to the U.S. market.”
The submission 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 studies, BXCL501
was well tolerated and met the primary and secondary endpoints at
the 120 mcg and 180 mcg doses, showing statistical significance
versus placebo in mean change 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. 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 trial (RELEASE) for
the treatment of opioid withdrawal symptoms and in a Phase 2 trial
(PLACIDITY) for the treatment of delirium related agitation.
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 the clinical benefits of BXCL501 to treat
agitation. 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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