BioXcel Therapeutics Highlights Upcoming Major Milestones
October 10 2019 - 8:00AM
BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI),
a clinical-stage biopharmaceutical development company utilizing
novel artificial intelligence approaches to identify and advance
the next wave of medicines in neuroscience and immuno-oncology,
today affirmed its expected timeline regarding upcoming milestones.
“We believe our recent equity offering
represents a key step in driving the success of our clinical
programs and providing sufficient funding to support key data
readouts, including clinical results from our lead neuroscience
program, BXCL501, as well as our immuno-oncology program, BXCL701,”
commented Vimal Mehta, Ph.D., Chief Executive Officer of BTI.
BXCL501, a differentiated, novel agent
intended for treatment of agitation in neuropsychiatric diseases,
demonstrated statistically significant results in a Phase 1b trial
in agitated Schizophrenia patients with clinically meaningful,
rapid and durable reduction in agitation. In addition, the results
from the Phase 1 trial with IV dexmedetomidine in Alzheimer’s
Disease patients produced rapid calming effects, as previously
announced.
“Given there are no FDA approved therapies and
that antipsychotics have black-box warnings for elderly
patients with dementia, we believe this is an opportune time to
continue to advance the clinical development of BXCL501 in
geriatric dementia, which has the potential to be a well-tolerated,
noninvasive treatment,” continued Mehta. “We are further encouraged
by the progress we have made in our BXCL701 program, with the first
data readout expected from the treatment emergent neuroendocrine
prostate cancer program in the fourth quarter of 2019. In addition,
we received U.S. Food and Drug Administration Orphan Drug
Designation for BXCL701 for the treatment of Acute Myeloid
Leukemia, representing a potential expansion of the program into
hematological malignancies.”
About BXCL501:
BXCL501 is an investigational, proprietary
sublingual thin film of dexmedetomidine, a selective alpha2 A
-adrenergic agonist designed 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 is currently being developed for agitation
associated with schizophrenia and bipolar disorders followed by
geriatric dementia/Alzheimer’s.
About BXCL701:
BXCL701 is an investigational orally-available
systemic innate immunity activator with dual mechanisms of action.
It has shown single agent activity in melanoma and safety has been
evaluated in more than 700 healthy subjects and cancer patients.
Designed to stimulate both the innate and acquired immune systems,
BXCL701 is designed to inhibit dipeptidyl peptidase (DPP) 8/9 and
block immune evasion by targeting Fibroblast Activation Protein
(FAP). BXCL701 is currently being developed for treatment of a rare
form of prostate cancer and for pancreatic cancer in combination
with other immuno-oncology agents.
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 and advance
the next wave of medicines 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
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 timing of the data
readouts for the BXCL501 and BXCL701 trials, the Company’s wearable
digital device initiative and the efficacy of BXCL501 in the
treatment of 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
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 Quarterly Report on Form 10-Q for
the quarterly period ended June 30, 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.comThe Ruth GroupCarol Ruth / James
Salierno646-536-7004 /
7028cruth@theruthgroup.comjsalierno@theruthgroup.com
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