BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience, today announced positive findings from
an independent third party audit of the data from a single site1 in
its TRANQUILITY II Phase 3 trial.
Conducted by a well-regarded regulatory and
quality consulting firm, the independent audit consisted of a
comprehensive review of records from over 50% of subjects enrolled
at the single trial site to identify any additional instance of
misconduct or fraud2 and to evaluate data integrity and reliability
for eligibility, safety, and efficacy data. This sample size
provides 95% confidence that the data reviewed is a representative
sample. Following an extensive review, the team of auditors did not
identify any findings that they believe impact the data reliability
or integrity, nor did they find any evidence of additional
misconduct or fraud. Based on these findings, BioXcel Therapeutics
believes that the positive, statistically significant TRANQUILITY
II trial data announced in June 2023 potentially support a
supplemental new drug application (sNDA) for BXCL501 for the acute
treatment of agitation associated with dementia in probable
Alzheimer’s disease.
“We believe these results of an audit by a
respected, independent firm validate the integrity of data from the
single site in question and add to the body of clinical evidence we
intend to include in our sNDA submission,” said Vimal Mehta, Ph.D.,
CEO of BioXcel Therapeutics. “We recently had a Type B/Breakthrough
meeting with the FDA to discuss our plans for the development of
BXCL501 for the acute treatment of agitation associated with
dementia in probable Alzheimer’s disease. We expect to receive the
FDA meeting minutes in the first half of November, and intend to
provide an update on additional steps for the TRANQUILITY program
and a potential sNDA in our upcoming third quarter financial
results.”
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience. The Company’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
indications. For more information, please
visit bioxceltherapeutics.com.
Forward-Looking Statements and
DisclaimersThis press release includes “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995. We intend such forward-looking statements to be
covered by the safe harbor provisions for forward-looking
statements contained in Section 27A of the Securities Act of 1933,
as amended (the “Securities Act”) and Section 21E of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”). All
statements contained in this press release other than statements of
historical fact should be considered forward-looking statements,
including, without limitation, statements regarding: the expected
receipt of the meeting minutes from FDA; additional steps for the
TRANQUILITY program and to support an sNDA for BXCL501 for the
acute treatment of agitation associated with dementia in probable
Alzheimer’s disease; the Company’s advancement of its product
candidates for regulatory approval; the representativeness of the
patient data audited; and the potential for the results from the
Company’s completed, ongoing and proposed clinical trials to
support regulatory approvals for its product candidates, including
the results from the TRANQUILITY II clinical trial. The words
“anticipate,” “believe,” “can,” “continue,” “could,” “designed,”
“estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,”
“plan,” “possible,” “potential,” “predict,” “project,” “should,”
“target,” “will,” “would” and similar expressions are intended to
identify forward-looking statements, though not all forward-looking
statements use these words or expressions. 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 the Company’s current expectations and
various assumptions. The Company believes there is a reasonable
basis for its expectations and beliefs, but they are inherently
uncertain. The Company 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 ability to
successfully negotiate amended terms under the financing agreements
to be able to access funding and to obtain relief under financial
covenants; its significant indebtedness and potential payment
obligations related to such indebtedness and other contractual
obligations; risks associated with the strategic reprioritization;
its limited experience in drug discovery and drug development;
risks related to the TRANQUILITY II Phase 3 trial and related
audit; its dependence on the success and commercialization of
IGALMI™, BXCL501, BXCL502, BXCL701 and BXCL702 and other product
candidates; its lack of experience in marketing and selling drug
products; the risk that IGALMI or the Company’s product candidates
may not be accepted by physicians or the medical community in
general; 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 the Company’s product
candidates; its novel approach to the discovery and development of
product candidates based on EvolverAI; the significant influence of
and dependence on BioXcel LLC; its exposure to patent infringement
lawsuits; its reliance on third parties; its ability to comply with
the extensive regulations applicable to it; impacts from data
breaches or cyber-attacks, if any; impacts from the COVID-19
pandemic; risks associated with the increased scrutiny relating to
environmental, social and governance (ESG) matters; 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, 2023,
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 the Company 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 the Company’s views as of any date subsequent to the
date of this press release.
The Company cannot guarantee that the FDA will
accept or agree with the Company’s or its auditors’ conclusions or
analyses, and the FDA may interpret or weigh their importance
differently. Further, if the FDA determines that there are issues
with data integrity and/or compliance with good clinical practice
requirements in connection with the TRANQUILITY II trial, the
Company may be unable to use some or all of the subject data
generated to support a marketing application, which could result in
inadequate powering of the TRANQUILITY II trial and failure to
reach statistical significance.
Contact Information
CorporateBioXcel TherapeuticsErik
Kopp1.203.494.7062ekopp@bioxceltherapeutics.com
Investor RelationsBioXcel TherapeuticsBrennan
Doyle1.475.355.8462bdoyle@bioxceltherapeutics.com
MediaRusso PartnersDavid
SchullT: 858-717-2310David.schull@russopartnersllc.comScott
StachowiakT: 646-942-5630Scott.stachowiak@russopartnersllc.com
Source: BioXcel Therapeutics, Inc.
BT BIOXCEL THERAPEUTICS is a registered trademark of BioXcel
Therapeutics, Inc. All other trademarks are the properties
of their respective owners. Copyright © 2023, BioXcel
Therapeutics, Inc. All rights reserved.
1 For additional information, see the Company’s Current Report
on Form 8-K, filed with the Securities and Exchange Commission on
June 29, 2023.2 For purposes of the audit, (1) misconduct was
defined to mean the negligent or intentional non-compliance with
relevant standards and regulations, or the deliberate or
intentional disregard for the protocol, policies and procedures,
and regulatory requirements or otherwise engaging in practices that
seriously deviate from commonly accepted research principles and
compromise the safety of subjects or the quality and/or integrity
of data or documents generated in the study, to include
falsification, fabrication, and forgery and (2) fraud was defined
to mean the deliberate reporting of false or misleading data or
information, or the deliberate withholding of reportable data.
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