BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience and immuno-oncology, today announced a
key executive promotion and a clinical advisor appointment as part
of the Company’s strategic reprioritization focused on the
advancement of its late-stage clinical programs and emerging
pipeline candidates.
Vincent J. O’Neill, M.D., Senior Vice President and Chief
Research & Development Officer of OnkosXcel Therapeutics, has
been promoted to Executive Vice President, Chief of Product
Development and Medical Officer of BioXcel
Therapeutics. He will lead clinical, regulatory and
medical affairs to provide a fully integrated
approach to product development. Additionally, Rajiv Patni, M.D.,
has been appointed to the newly created position of Strategic
Clinical Advisor to the BioXcel Therapeutics Chief Executive
Officer and Board of Directors.
“Our strategic focus has shifted to expanding the market
opportunities for our lead program BXCL501 in the at-home
setting, which we believe represent key value drivers for the
Company. We are adding to the strength of our existing team and
expanding our clinical leadership in line with our
prioritization of late-stage TRANQUILITY and
SERENITY III programs for BXCL501’s potential use to
treat Alzheimer’s, bipolar disorder, and schizophrenia-related
agitation,” said Vimal Mehta, Ph.D., CEO of BioXcel
Therapeutics. “We are also excited to
advance development candidates identified through
our AI-driven approach as part of our efforts to build a
sustainable R&D pipeline. The promotion of Vince
and the appointment of Rajiv are in support of our
clinical execution, and we welcome their
strong leadership as we look to
progress in 2024.”
Vincent J. O’Neill, M.D.: Executive Vice President,
Chief of Product Development and Medical
Officer
Dr. O’Neill has significant expertise in therapeutic and
diagnostic product development. He joined BioXcel Therapeutics in
2017 as Vice President and Chief Medical Officer, later Senior Vice
President and Chief Medical Officer, and played an instrumental
role in the Company’s SERENITY I and II trials of BXCL501, which
contributed to the FDA approval of IGALMI™ (dexmedetomidine)
sublingual film for the acute treatment of agitation associated
with schizophrenia and bipolar I or II disorder in adults. He also
led the Company’s immuno-oncology program and the successful human
proof of concept trials for BXCL701, an investigational, orally
administered systemic innate immune activator for the treatment of
refractory forms of prostate cancer. In 2022, he became Senior Vice
President and Chief Research & Development Officer of the
Company’s wholly owned OnkosXcel Therapeutics subsidiary.
Prior to joining BioXcel Therapeutics, Dr. O’Neill held senior
leadership roles at several leading global pharmaceutical
companies, including Sanofi, Genentech, and GlaxoSmithKline. Most
recently, he served as Chief Medical Officer at Mirna Therapeutics
and Exosome Diagnostics. He was instrumental in the expanded
approvals of Genentech’s oncology therapeutics, Avastin® and
Tarceva®. At GSK, he oversaw the signal transduction discovery unit
and led the first IND application and clinical trial of the MEK
inhibitor, MEKINIST®. Dr. O’Neill has authored several
peer-reviewed publications and conference presentations. He
received his M.D. and B.Sc. in Molecular Pathology from the
University of Glasgow, Scotland, and is a member of the Royal
College of Physicians.
Rajiv Patni, M.D.: Strategic Clinical Advisor to the
BioXcel Therapeutics CEO and Board of Directors
Dr. Patni was Chief Research and Development Officer at Reata
Pharmaceuticals, a commercial-stage company recently acquired by
Biogen. Previously, he was a successful Chief Medical Officer at
several public, small-cap, commercial-stage biopharmaceutical
companies: Adamas, Portola, and Global Blood Therapeutics. He
joined these companies at an inflection point in their R&D
growth trajectories and contributed to their acquisition by larger
companies. Earlier in his career, Dr. Patni had roles of increasing
responsibility at Pfizer, Roche, and Actelion.
Over his 23-year industry tenure in global product development,
Dr. Patni has contributed to the development of 21 NCEs for both
common and, most recently, rare diseases. His experience in
fostering successful team efforts at these different companies
contributed to the approval of 10 medicines, from the U.S. FDA,
EMA, and other regulatory agencies. Dr. Patni received his M.D.
degree from the Mount Sinai School of Medicine in New York City as
part of an accelerated B.S. /M.D. program. He completed his
internal medicine residency and adult cardiology fellowship at the
Albert Einstein College of Medicine, also in New York City, where
he continued as an attending physician-scientist before joining the
biopharmaceutical industry.
“I have been impressed by the Company’s AI-based discovery and
development of BXCL501, which was approved as IGALMI, and their
continued development of this asset for potential at-home treatment
of agitation associated with Alzheimer’s dementia, bipolar
disorders, and schizophrenia,” said Dr. Patni. “I look forward to
working with the BioXcel leadership team in continuing to address
the unmet medical needs of patients and caregivers and advance the
Company’s product-development goals.”
About IGALMI™ (dexmedetomidine) sublingual film
INDICATION
IGALMI™ (dexmedetomidine) sublingual film is a prescription
medicine, administered under the supervision of a health care
provider, that is placed under the tongue or behind the lower lip
and is used for the acute treatment of agitation associated with
schizophrenia and bipolar disorder I or II in adults. The safety
and effectiveness of IGALMI has not been studied beyond 24 hours
from the first dose. It is not known if IGALMI is safe and
effective in children.
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
- Decreased blood pressure, low blood pressure upon
standing, and slower than normal heart rate, which may be more
likely in patients with low blood volume, diabetes,
chronic high blood pressure, and older patients. IGALMI is taken
under the supervision of a healthcare provider who will monitor
vital signs (like blood pressure and heart rate) and alertness
after IGALMI is administered to help prevent falling or fainting.
Patients should be adequately hydrated and sit or lie down after
taking IGALMI and instructed to tell their healthcare provider if
they feel dizzy, lightheaded, or faint.
- Heart rhythm changes (QT
interval prolongation). IGALMI should not be given to
patients with an abnormal heart rhythm, a history of an irregular
heartbeat, slow heart rate, low potassium, low magnesium, or taking
other drugs that could affect heart rhythm. Taking IGALMI with a
history of abnormal heart rhythm can increase the risk of torsades
de pointes and sudden death. Patients should be instructed to tell
their healthcare provider immediately if they feel faint or have
heart palpitations.
- Sleepiness/drowsiness.
Patients should not perform activities requiring mental alertness,
such as driving or operating hazardous machinery, for at least 8
hours after taking IGALMI.
-
Withdrawal reactions, tolerance, and decreased response/efficacy.
IGALMI was not studied for longer than 24 hours after the first
dose. Physical dependence, withdrawal symptoms (e.g., nausea,
vomiting, agitation), and decreased response to IGALMI may occur if
IGALMI is used longer than 24 hours.
The most common side effects of
IGALMI in clinical studies were sleepiness or drowsiness, a
prickling or tingling sensation or numbness of the mouth,
dizziness, dry mouth, low blood pressure, and low blood pressure
upon standing.
These are not all the possible side effects of IGALMI. Patients
should speak with their healthcare provider for medical advice
about side effects.
Patients should tell their healthcare provider about
their medical history, including if they suffer from any
known heart problems, low potassium, low magnesium, low blood
pressure, low heart rate, diabetes, high blood pressure, history of
fainting, or liver impairment. They should also tell their
healthcare provider if they are pregnant or breastfeeding or take
any medicines, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Patients should
especially tell their healthcare provider if they take any drugs
that lower blood pressure, change heart rate, or take anesthetics,
sedatives, hypnotics, and opioids.
Everyone is encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You
can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088
or medinfo@bioxceltherapeutics.com.
Please see full Prescribing
Information at igalmi.com.
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a
biopharmaceutical company utilizing artificial intelligence to
develop transformative medicines in neuroscience and
immuno-oncology. 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 This 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, its expectations regarding its development programs and
anticipated contributions of Drs. O’Neill and Patni. When used
herein, words including “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, the important
factors discussed under the caption “Risk Factors” in its Quarterly
Report on Form 10-Q for the quarterly period ended September 30,
2023, 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 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.
Contact Information
Corporate
BioXcel TherapeuticsErik
Kopp1.203.494.7062ekopp@bioxceltherapeutics.com
Investor Relations
BioXcel TherapeuticsBrennan
Doyle1.475.355.8462bdoyle@bioxceltherapeutics.com
Media
Russo PartnersDavid
SchullT: 858-717-2310David.Schull@russopartnersllc.comScott
StachowiakT: 646-942-5630Scott.Stachowiak@russopartnersllc.com
Source: BioXcel Therapeutics, Inc.
*IGALMI is a trademark of 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.
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