BioXcel Therapeutics Announces FDA Acceptance of IND for Lead Neuroscience Candidate, BXCL501 for the Acute Treatment of Agit...
December 12 2018 - 4:00AM
First-in-human pharmacokinetic (bioavailability)
study with sublingual thin-film formulation Patient
recruitment initiated and data read-out expected in 1H
19 Results to support dose selection for registration trial
expected to initiate in 2019
BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI),
today announced that the U.S. Food and Drug Administration (“FDA”),
has accepted its Investigational New Drug (IND) application for
lead neuroscience candidate, BXCL501. BTI plans to evaluate
BXCL501, a proprietary sublingual thin-film formulation of
dexmedetomidine (Dex) in a first-in-human pharmacokinetic
(bioavailability) and safety study in healthy volunteers. BTI is a
clinical-stage biopharmaceutical development company utilizing
novel artificial intelligence approaches to identify the next wave
of medicines across neuroscience and immuno-oncology.
Dr. Chetan D. Lathia, Senior Vice President
& Head of Translational Medicine, Clinical Pharmacology &
Regulatory Affairs of BTI commented "Clinical supplies with
multiple dosing strengths of BXCL501 are now available to initiate
clinical trials. With the FDA acceptance of the IND, we are
on-track to dose subjects by year-end, with data expected in the
first half of 2019.The results of this study will help in the
determination of doses for our planned registration study.”
Dr. Vimal Mehta, Chief Executive Officer of BTI
added, “As a result of this IND acceptance, our second clearance
this quarter, we have two active clinical studies for our lead
programs in neuroscience and immuno-oncology. The initiation of
these studies further validates our unique approach to drug
development, which leverages the power of artificial intelligence
to optimize research and development economics, improve development
efficiency and speed to market. Given the ease of administration
and other advantages of our proprietary sublingual thin-film
formulation, we believe that BXCL501 has the potential to address
the large unmet medical need and significant healthcare burden
associated with the acute treatment of agitation.”
The IND-opening Phase 1 study is a
placebo-controlled, single‑dose, dose-escalation study of BXCL501
that is expected to enroll up to 60 healthy adult volunteers across
various dosing groups. The primary endpoints are pharmacokinetics
and safety, with secondary endpoints including assessment of
pharmacodynamics (PD) and the relationship between BXCL501
concentrations and PD endpoints. The Company expects to report
top-line data from the study in the first half of 2019 that will
provide a path for BTI to launch the anticipated registration
studies.
BTI continues to explore expanding the range of
target indications for BXCL501 beyond its current focus areas of
acute treatment of agitation in schizophrenia, bipolar disorder and
dementia. Treatment of agitation remains a significant global
healthcare challenge in patients with drug and alcohol withdrawal,
delirium and post-traumatic stress disorder, as the currently
available treatment options are suboptimal, invasive, difficult to
administer and often pose safety issues.
About BXCL501:BXCL501 is a
first in class, proprietary sublingual film of dexmedetomidine, a
selective alpha 2a receptor agonist intended for the treatment of
acute agitation. BTI believes that BXCL501 directly targets a
causal agitation mechanism and has demonstrated anti-agitation
effects in preclinical and clinical studies. It has a
well-established regulatory and reimbursement path for the acute
treatment of agitation in schizophrenia and bipolar disorder, as
demonstrated by Adasuve, a drug previously-approved by the FDA.
About Treatment of
AgitationAgitation, including the acute treatment of
agitation, remains a growing global healthcare burden. The Company
estimates the total direct financial cost of all aspects of care
for agitation in Alzheimer’s disease to be approximately $40
billion per year. The Company believes approximately 5.0 million
patients with Alzheimer’s disease, schizophrenia and bipolar
disorder experience agitation in the U.S. Approximately 1.1 million
of these patients experience mild to moderate agitation and
represent a potential patient population for treatment with
BXCL501.
About BioXcel Therapeutics,
Inc.:BioXcel Therapeutics, Inc. is a clinical stage
biopharmaceutical company focused on drug development that utilizes
novel artificial intelligence approaches to identify the next wave
of medicines across neuroscience and immuno-oncology. BTI'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. BTI's two most advanced clinical development programs are
BXCL501, a sublingual thin film formulation designed for acute
treatment of agitation resulting from neurological and psychiatric
disorders, and BXCL701, an immuno-oncology agent designed for
treatment of a rare form of prostate cancer and for treatment of
pancreatic cancer. 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, statements that relate to the advancement and
development of BXCL501 and BXCL701, the commencement of clinical
trials, the availability of data from clinical trials and other
information that is not historical information. When used herein,
words such as “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, market conditions and the factors described
under the caption “Risk Factors” in BioXcel’s Form 10Q for the
period ending September 30, 2018, and BioXcel’s other filings made
with the Securities and Exchange Commission. Consequently,
forward-looking statements should be regarded solely as BioXcel’s
current plans, estimates and beliefs. Investors should not place
undue reliance on forward-looking statements. BioXcel cannot
guarantee future results, events, levels of activity, performance
or achievements. BioXcel does not undertake and specifically
declines any obligation to update, republish, or revise any
forward-looking statements to reflect new information, future
events or circumstances or to reflect the occurrences of
unanticipated events, except as may be required by law.
Contact Information: The Ruth Group for BTI:
Lee Roth / Janhavi Mohite 646-536-7012 / 7026
lroth@theruthgroup.com / jmohite@theruthgroup.com
BioXcel Therapeutics (NASDAQ:BTAI)
Historical Stock Chart
From Mar 2024 to Apr 2024
BioXcel Therapeutics (NASDAQ:BTAI)
Historical Stock Chart
From Apr 2023 to Apr 2024