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 the
initiation of the Phase 2 PLACIDITY trial of BXCL501, the Company’s
investigational, proprietary, orally dissolving thin film
formulation of dexmedetomidine (“Dex”), for the treatment of
delirium related agitation.
“The initiation of PLACIDITY marks an important milestone in our
efforts to showcase BXCL501’s ability to calm patients struggling
with delirium related agitation, our fifth potential indication for
this candidate,” commented Vimal Mehta, Chief Executive Officer of
BioXcel. “Treating agitation associated with delirium remains a
challenge for healthcare workers and patients as there are no
FDA-approved therapies and off-label treatments are suboptimal,
resulting in serious medical complications and extended hospital
stays. We believe BXCL501, if approved, would be a welcomed therapy
option for the approximately 4 million U.S. patients suffering from
delirium related agitation annually, and we look forward to
reporting topline results in the first quarter of 2022. Moreover,
since delirium occurs across treatment settings within a hospital,
this potential indication would be synergistic with the commercial
infrastructure we are currently building to support our first New
Drug Application.”
The PLACIDITY trial is a multicenter, randomized, double-blind,
placebo-controlled, ascending dose-finding, adaptive Phase 2 study
designed to evaluate the safety, efficacy, and pharmacokinetics of
BXCL501 in intensive care unit adult patients experiencing delirium
related agitation, including COVID-19 patients. Approximately 20
patients will be randomized into each sequential ascending dose
cohort of BXCL501 (starting doses of 120 ug, 180 ug, 240 ug, or 300
ug), or matching placebos to determine an optimal starting dose
that could effectively and safely reduce agitation. Elderly
delirium patients (65 years or older) in these cohorts will receive
half the dose. The primary endpoint is the reduction in agitation
measured by at least a 2-point drop in the Richmond Agitation
Sedation Scale (“RASS”) at two hours post BXCL501 administration.
The secondary endpoint is the earliest time at which a 2-point drop
is seen in RASS after BXCL501 administration. An exploratory
endpoint of this trial will be to determine the overall clinical
improvement after drug administration using the Clinical Global
Impression – Improvement Scale (“CGI-I”).
About Delirium Related Agitation:Delirium is a
serious condition that occurs in a variety of hospital settings,
including frequently in the intensive care unit. This condition may
be caused by numerous underlying pathologic processes and disease
states. Delirium is known to cause public health burden due to
extended hospital stays, medical complications, increased financial
costs and increased mortality. Delirium related agitation occurs in
the majority of patients with this condition. Agitated patients
with delirium are unable to calm themselves, rest or sleep and
often self-extubate, remove catheters and IV lines thus
complicating overall patient care. With no FDA-approved treatments
for this condition, current guidelines recommend sedative
medications to maintain a light level of sedation in adult
patients, which is frequently not achieved with commonly used
therapies. A therapy that quickly and effectively reduces
agitation, without causing excessive sedation, is needed to speed
up recovery time and improve patient outcomes.
About the Richmond Agitation Sedation Scale
(“RASS”)The most commonly used and recommended instrument
for agitation assessment in the ICU is the Richmond
Agitation-Sedation Scale (“RASS”). The Richmond Agitation–Sedation
Scale was developed in a collaborative effort with practitioners
representing critical care physicians, nurses, and pharmacists and
its validation and reliability is well documented. RASS is a
10-point scale that ranges from +4 to -5. There are four point
levels to assess agitation (+4 to +1), a single point level to
denote a calm and alert state (0), and five point levels to assess
sedation (-1 to -5). On one end of the RASS score, +4 represents a
very combative, violent patient, who is dangerous to the staff. On
the other end, -5 represents a patient who is unarousable, with no
response to voice or physical stimulation.
About BXCL501BXCL501 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 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 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 and data from the Phase 2 PLACIDITY trial for BXCL501,
synergy of the delirium indication with the Company’s planned
commercial structure, value of BXCL501 as a treatment option, and
the Company’s planned new drug application. 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.
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
BioXcel Therapeutics (NASDAQ:BTAI)
Historical Stock Chart
From Aug 2024 to Sep 2024
BioXcel Therapeutics (NASDAQ:BTAI)
Historical Stock Chart
From Sep 2023 to Sep 2024