BioXcel Therapeutics Achieved Targeted Exposures of BXCL501 Designed For Non-Invasive Acute Treatment of Agitation in Neurops...
May 20 2019 - 7:30AM
BioXcel Therapeutics, Inc. (“BTI” or the “Company”) (Nasdaq: BTAI),
today announced positive top line data from its Phase 1
pharmacokinetic (PK) (bioavailability) and safety study of BXCL501,
a proprietary sublingual thin-film formulation of dexmedetomidine
(Dex), for the acute treatment of agitation across multiple
neuropsychiatric indications. Administration of BXCL501 in the
Phase 1 pharmacokinetic and safety study successfully achieved
targeted exposure levels that were observed to be therapeutic in
the Company’s prior IV Dex study and BTI intends to advance BXCL501
into a Phase 2 trial to evaluate efficacy in agitated schizophrenia
patients. We believe the results from the Phase 2 study are
expected to facilitate powering of a planned Phase 3 pivotal trial.
BTI is a clinical-stage biopharmaceutical development company
utilizing novel artificial intelligence approaches to identify and
advance next wave of medicines in neuroscience and immuno-oncology.
The IND-opening Phase 1 study was a double-blinded
placebo-controlled, single-dose, dose-escalation study of BXCL501
that enrolled 42 adult volunteers across various dosing groups. The
primary endpoints of the study were PK and safety, while secondary
endpoints included assessment of pharmacodynamics (PD) and the
relationship between BXCL501 concentrations and PD endpoints.
Findings from the study indicate that BXCL501 rapidly achieved
targeted exposure levels consistent with the levels observed in the
intravenous (“IV”) Dex study in schizophrenia patients that the
Company announced in November 2018. Results from the Phase 1 study
also showed dose-proportional PK consistent with the IV Dex study
with PD effects lasting 4 to 6 hours, which we believe are
clinically favorable features.
Additionally, clinical data from the study indicates BXCL501 was
well tolerated. There were no serious adverse events. The most
common adverse event was drowsiness, observed at rates similar to
placebo. All adverse events were mild to moderate and transient.
There was no clear sedative effect in comparison with placebo.
Cardiovascular changes were not clinically meaningful. A maximum
tolerated dose was not reached.
Vimal Mehta, Ph.D., Chief Executive Officer of BTI, added, “We
are excited to report that sublingual administration of BXCL501 in
our Phase 1 study achieved drug exposures that we believe will be
therapeutic in the acute treatment of agitation. Additionally, the
PK profile of sublingual BXCL501 demonstrated dose proportionality
and suggests the potential for a rapid onset of
action. Agitation is believed to represent a multibillion
dollar burden to the healthcare system severely lacking effective
non-invasive treatment options. We believe that robust datasets
from this new Phase 1 PK and safety study provide a strong
rationale for advancing the clinical development of the BXCL501
program. With successful completion of this study and positive
findings, we are now a step closer to our objective of potentially
providing acutely agitated patients with a non-invasive and
easy-to-administer treatment option.”
Robert Risinger, M.D., Vice President, Clinical Development of
BTI, commented, “We are pleased to advance our potent selective
alpha-2 agonist, BXCL501, by expanding our
clinical development program. Multiple proof-of-concept
studies have shown that Dex produced a calming effect in
illnesses where agitation is a common
symptom. If approved, we believe BXCL501 may offer patients
and physicians a novel approach to treat
acute agitation associated with a broad spectrum of
conditions. We believe that BXCL501 may provide rapid relief in a
delivery form that can easily be administered in all clinical
settings where agitated patients are encountered.”
Conference Call:BTI will host a conference call
today at 8:30 a.m. ET. To access the call please dial
1-800-289-0438 (domestic) and 1-323-994-2082 (international) and
provide the passcode 2971079. A live webcast of the call and a copy
of the Company’s presentation materials that will be discussed on
the call will be available on the Investors sections of the BTI
website at www.bioxceltherapeutics.com. The archived webcast will
be available through June 20, 2019.
About BXCL501:BXCL501 is a potential first- in-
class, 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 using IV (intravenous) Dex has shown
anti-agitation effects in multiple clinical studies.
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 next wave of
medicines in 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 neuropsychiatric disorders,
and BXCL701, an orally administered systemic innate immunity
activator designed 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 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,
statements that relate to the advancement and development of
BXCL501 and BXCL701, the commencement of clinical trials, the
availability and results of data from clinical trials, the planned
timing of BTI’s submission of its first New Drug Application with
the FDA and other information that is not historical information.
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 period ended March 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 TherapeuticsThe
Ruth GroupJanhavi
Mohite646-536-7026
jmohite@theruthgroup.com Source: BioXcel Therapeutics, Inc.
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