BioXcel Therapeutics Provides an Update on its Ongoing Phase 3 SERENITY Trials
March 19 2020 - 7:15AM
BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a
clinical-stage biopharmaceutical company utilizing artificial
intelligence to identify improved therapies in neuroscience and
immuno-oncology, today announced that more than one-third of the
patients in the Phase 3 SERENITY trials have been enrolled and
treated. To date, the company has not observed a change in
enrollment rates resulting from the COVID-19 pandemic, and
currently maintains previous guidance that SERENITY I & II are
expected to be completed by mid-year 2020.
“Despite the current situation with COVID-19, we
remain on track with the enrollment of our SERENITY studies,”
stated Vimal Mehta, Chief Executive Officer of BTI. “Up to now, all
schizophrenia and bipolar patients enrolled have successfully
self-administered the BXCL501 treatment, guided by a healthcare
provider, and the trials seem to be progressing well. We are
optimistic that enrollment rates will continue to stay consistent
with previous weeks and are looking forward to sharing topline
results in the middle of this year.”
The SERENITY studies are randomized,
double-blinded, placebo-controlled, adaptive trials of up to 750
patients, 18 to 75 years of age. SERENITY I is enrolling patients
with agitation associated with schizophrenia, with each arm
receiving BXCL501 at 120 micrograms, 180 micrograms or placebo,
respectively. SERENITY II is evaluating patients with agitation
associated with bipolar disorder, also in three arms receiving
BXCL501 at 120 micrograms, 180 micrograms or placebo, respectively.
The primary endpoint of the trials is reducing acute agitation
measured by the Positive and Negative Syndrome Scale, examining the
Excited Component (“PEC”) change from baseline compared to placebo.
A key secondary endpoint includes determining the earliest time
where an effect on agitation is apparent as measured by the change
from baseline in PEC total score.
About Agitation in
NeuropsychologyAgitation is a common and difficult to
manage symptom associated with a number of psychiatric conditions,
including schizophrenia and bipolar disorder. It is estimated that
approximately 19 million people are at risk of agitation, and 8.3
million in the U.S. suffer from agitation each year, costing
approximately $40 billion annually in treatment related expenses.
Early identification and prompt intervention to relieve agitation
are essential to avoid symptomatic escalation and emergence of
aggression. Recent consensus guidelines emphasize the need for
non-coercive management strategies to protect the therapeutic
alliance between patients and their healthcare providers—an
alliance that is critical for the effective management of chronic
psychiatric conditions. A non-invasive therapy that causes rapid
symptom relief and de-escalates agitation may be necessary to avoid
the costly and traumatic use of coercive techniques, like physical
restraint and seclusion, which require admission and prolonged
hospitalization.
About BXCL501
BXCL501 is an investigational proprietary
sublingual thin film of dexmedetomidine, a selective alpha-2a
receptor agonist for the treatment of acute agitation. BTI believes
that BXCL501 directly targets a causal agitation mechanism, and the
Company has observed anti-agitation effects in multiple clinical
studies across multiple neuropsychiatric indications. BXCL501 has
been granted Fast Track Designation by the U.S. Food and Drug
Administration for the acute treatment of agitation.
A Phase 1b safety and efficacy study of BXCL501
in patients with schizophrenia yielded positive dose-response data.
BXCL501 is being evaluated in the SERENITY program, consisting of
two Phase 3 studies for the acute treatment of agitation in
patients with schizophrenia (SERENITY I) and bipolar disorder
(SERENITY II). BXCL501 is also being evaluated in a Phase 1b/2
trial (TRANQUILITY) for the treatment of agitation associated with
dementia, and the Company is preparing to initiate a Phase 1b/2
study (RELEASE) of BXCL501 for the treatment of opioid withdrawal
symptoms.
About BioXcel Therapeutics,
Inc.:
BioXcel Therapeutics, Inc. is a clinical-stage
biopharmaceutical company utilizing artificial intelligence to
identify improved therapies in neuroscience and immuno-oncology.
BTI's drug re-innovation approach leverages existing approved drugs
and/or clinically evaluated product candidates together with big
data and proprietary machine learning algorithms to identify new
therapeutic indices. BTI's two most advanced clinical development
programs are BXCL501, an investigational sublingual thin film
formulation in development for acute treatment of agitation
resulting from neuropsychiatric disorders, and BXCL701, an
investigational orally administered systemic innate immunity
activator in development for treatment of a rare form of prostate
cancer and for treatment of pancreatic cancer in combination with
other immuno-oncology agents. For more information, please visit
http://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 enrollment of patients in the Phase 3 SERENITY
trials and the timing of topline data from these trials. 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 BTI's current expectations and various assumptions.
BTI believes there is a reasonable basis for its expectations and
beliefs, but they are inherently uncertain.
BTI 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;
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; its ability to commercialize its
product candidates; and the other important factors discussed under
the caption “Risk Factors” in its Annual Report on Form 10-K for
the fiscal year ended December 31, 2019, 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.
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 BTI 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 BTI’s views as
of any date subsequent to the date of this press release.
Contact Information:
BioXcel Therapeutics,
Inc.www.bioxceltherapeutics.com
Investor Relations:John
Grazianojgraziano@troutgroup.com1.646.378.2942
Media:Julia
Deutschjdeutsch@troutgroup.com1.646.378.2967
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