BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical
company utilizing artificial intelligence to develop transformative
medicines in neuroscience, today announced an update on the
National Institute on Drug Abuse (NIDA)-funded trial evaluating
BXCL501 (sublingual dexmedetomidine) as a potential treatment for
opioid use disorder (OUD).
BioXcel Therapeutics is supplying BXCL501 for an ongoing 4-arm,
160-patient trial that is enrolling patients who have been
predominantly exposed to fentanyl and/or predominantly exposed to
fentanyl adulterated or associated with xylazine (FAAX), which has
been designated an emerging threat by the White House Office of
National Drug Control Policy1. NIDA has requested Columbia
University, the trial coordinator, to add a fourth site to target
trial completion in 2024. After this time, BioXcel Therapeutics
plans to seek FDA feedback on potential registrational paths.*
According to NIDA, xylazine has been linked to an increasing
number of overdose deaths nationwide in the evolving drug addiction
and overdose crisis. Studies show people exposed to xylazine often
knowingly or unknowingly used it in combination with other drugs,
particularly illicit fentanyl.2 Recently, the Biden
administration requested $46 billion in its fiscal 2024 National
Drug Control Budget3 to address the opioid epidemic, while opioid
settlements reached between U.S. state and local governments and
the 14 major pharmaceutical opioid manufacturers, distributors, and
retailers have aggregated between $51 billion and nearly $55
billion.4
“We have long known that the locus coeruleus drives various
opioid withdrawal symptoms5 but have lacked access to a sublingual
formulation of dexmedetomidine, one of the most potent and
selective alpha 2-adrenergic receptor agonists available, as a
treatment option,” said Dr. Sandra Comer, Principal Investigator of
the trial and Professor of Neurobiology in the Department of
Psychiatry at Columbia University. “With BXCL501, we are excited
about the potential to treat patients who are physically dependent
on illicit and prescription opioids. We believe dexmedetomidine
might be particularly helpful in treating withdrawal symptoms in
patients who are dependent on fentanyl and/or fentanyl adulterated
with xylazine.”
Between June 2020 and January 2021, Columbia University enrolled
patients in the Company’s RELEASE trial — a multicenter,
randomized, double-blind, placebo-controlled, ascending-dose Phase
1b/2 trial designed to evaluate the safety, pharmacokinetics,
tolerability, and efficacy of BXCL501 administered twice daily for
seven days — in patients experiencing opioid withdrawal symptoms.
In March 2021, BioXcel Therapeutics announced RELEASE topline
results. BXCL501 was generally well tolerated, with no severe or
serious adverse events reported across all doses evaluated (30
mcg, 60 mcg, 90 mcg, 120 mcg, 180 mcg, and 240
mcg). After further post-hoc analysis, a peer-review article
published in the American Journal of Drug and Alcohol Abuse in
January 2023 6 reported that the 240 mcg BID dose (480 mcg per day)
was well tolerated, demonstrated statistically significant
reduction in both Clinical Opiate Withdrawal Scale (COWS) and
Subjective Opiate Withdrawal Scale (SOWS), and demonstrated a
greater completion of treatment among enrolled patients, 87% of
whom had been exposed to fentanyl. In August 2022, the Company
announced an NIH NIDA grant to Columbia University to support
further studies of BXCL501 for the treatment of OUD.
“While BXCL501 has already demonstrated statistical significance
in patients exposed to fentanyl, this current study has a high
proportion of patients exposed to FAAX and is comparing 180 mcg and
240 mcg BID doses to both placebo and the standard of care,
lofexidine,” said Robert Risinger, M.D., Chief Medical Officer,
Neuroscience of BioXcel Therapeutics. “BXCL501 is one of the only
potential treatments being studied in this patient population and
represents an important potential option to help address the
growing OUD crisis.”
The BXCL501 OUD trial is supported by the National Institute on
Drug Abuse of the National Institutes of Health (NIH) under award
number UG3DA056247.
*In 2017, the U.S. federal government determined that a public
health emergency under the Public Health Service Act for the opioid
crisis existed, and this determination was recently renewed for 90
days in September 2023, although such public health emergency is
independent from any public health emergency determined under the
Federal Food, Drug, and Cosmetic Act. A separate determination
under the act has not been issued and would be a prerequisite for
FDA to declare that circumstances exist justifying emergency use of
drugs to address the public health emergency, which must occur
before FDA is authorized to issue emergency use authorizations for
OUD drugs. The Company may consider advocating for such
determination under the Federal Food, Drug and Cosmetic Act, as
well as a declaration from the government that drugs targeting OUD
are eligible for the emergency use authorization path to market,
though they are not currently permitted under the law to be
authorized pursuant to this pathway today.
Government-Supported Investigator-Initiated Trial
Programs for BXCL501 and Commercialization
OpportunitiesBioXcel Therapeutics has retained all rights
to the commercialization of BXCL501 in all potential indications
evaluated in clinical trials supported by the U.S. government. In
addition to OUD as an indication, BioXcel Therapeutics has been
awarded key opportunities for the development of BXCL501 in
post-traumatic stress disorder and alcohol use disorder. These are
being funded through cooperative agreements with the U.S.
Department of Defense Congressionally Directed Medical Research
Program and NIDA. Clinical and regulatory responsibilities are
being led by clinical researchers and regulatory staff at Columbia
University New York State Psychiatric Institute, the Veterans
Affairs Connecticut Healthcare System, Yale University Medical
School, RTI International, and NIDA.
About BXCL501In indications other than those
approved by the FDA as IGALMI™, BXCL501 is an investigational
proprietary, orally dissolving film formulation of dexmedetomidine,
a selective alpha-2 adrenergic receptor agonist. BioXcel
Therapeutics believes that BXCL501 potentially targets an important
mediator of agitation, and the Company has observed anti-agitation
results in multiple clinical studies across several
neuropsychiatric disorders. BXCL501 is under investigation by
BioXcel Therapeutics for the acute treatment of agitation
associated with dementia due to probable Alzheimer’s disease and
for the acute treatment of agitation associated with bipolar I or
II disorder or schizophrenia in the at-home setting. The safety and
efficacy of BXCL501 for these investigational uses have not been
established. BXCL501 has been granted Breakthrough Therapy
designation for the acute treatment of agitation associated with
dementia and Fast Track designation for the acute treatment of
agitation associated with schizophrenia, bipolar disorders, and
dementia.
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
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, statements regarding: expected timing of, trial design
and data results from, clinical trials of BXCL501, the potential
addressable market for BXCL501, potential registrational paths and
potential advocating activities relating to BXCL501, the potential
for BXCL501 to treat opioid withdrawal symptoms and potential
benefits of such treatment. 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; risks associated
with the strategic reprioritization; its limited experience in drug
discovery and drug development; 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; undesirable side effects caused by the
Company’s product candidates; its exposure to patent infringement
lawsuits; its reliance on third parties; 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, 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.
Contact Information
Corporate
BioXcel 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.
References
- Whitehouse.gov. Biden-Harris Administration Designates Fentanyl
Combined with Xylazine as an Emerging Threat to the United States.
Accessed November 1, 2023. Accessed November 1, 2023.
https://www.whitehouse.gov/ondcp/briefing-room/2023/04/12/biden-harris-administration-designates-fentanyl-combined-with-xylazine-as-an-emerging-threat-to-the-united-states/
- nida.nih.gov. Research Topics. Accessed November 2, 2023.
https://nida.nih.gov/research-topics/xylazine
- Whitehouse.gov. National Drug Control Budget FY2024 Funding
Highlights March 2023. Accessed November 1, 2023.
https://www.whitehouse.gov/wp-content/uploads/2023/03/FY-2024-Budget-Highlights.pdf
- Opioidsettlementtracker.com. Global Settlement Tracker.
Accessed November 1, 2023.
https://www.opioidsettlementtracker.com/globalsettlementtracker
- Rasmussen K 1991. Afferent effects on locus coeruleus in opiate
withdrawal. Prog Brain Res. 1991;88:207-16. doi:
10.1016/s0079-6123(08)63810-8. PMID: 1839935.
- Jones JD, Rajachandran L, Yocca F, Risinger R, De Vivo M,
Sabados J, Levin FR, Comer SD. Sublingual dexmedetomidine (BXCL501)
reduces opioid withdrawal symptoms: findings from a multi-site,
phase 1b/2, randomized, double-blind, placebo-controlled trial. Am
J Drug Alcohol Abuse. 2023 Jan 2;49(1):109-122. doi:
10.1080/00952990.2022.2144743. Epub 2023 Jan 11. PMID:
36630319.
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