Anebulo Pharmaceuticals Awarded NIDA Grant for its Investigational IV Treatment for Acute Cannabis-Induced Toxic Effects
22 Julio 2024 - 6:00AM
Business Wire
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a
clinical-stage biopharmaceutical company developing novel solutions
for people suffering from acute cannabis-induced toxic effects (the
“Company” or “Anebulo”), has been awarded the first tranche of a
two year cooperative grant of up to approximately $1.9 million from
the National Institute on Drug Abuse (“NIDA”), part of the National
Institutes of Health (“NIH”), to support the development of
intravenous selonabant, for the potential use as an emergency
treatment of acute cannabis-induced toxicities, including
cannabis-induced CNS depression in children. The grant comes in the
form of two tranches with the initial award of $0.9 million and
subsequent funding of approximately $1 million subject to certain
milestones. The grant was awarded under NIH award number
1U01DA059995-01.
“We are honored to receive this cooperative grant award from
NIDA to support the further development of intravenous selonabant,”
commented Ken Cundy, CSO of Anebulo Pharmaceuticals. “We believe
this provides additional validation of the significant and growing
unmet medical need for an emergency antidote to cannabis. Acute
cannabis exposure in children represents a potentially
life-threatening condition that can result in CNS depression,
respiratory depression, coma, and in rare cases death. Research has
shown that children are much more sensitive to the toxic effects of
cannabis. Younger children have an underdeveloped endocannabinoid
system with significantly more of the primary cannabinoid receptor
type 1 (CB1) receptors present in their brains. As a direct
consequence, pediatric cannabis ingestion can result in much more
serious outcomes than in adults, and a much greater risk of
hospitalization and admission to intensive care.”
“This important grant from NIDA recognizes the progress we have
already made with the successful Phase 2 proof of concept study of
oral selonabant and provides further momentum for advancing the
intravenous formulation towards clinical testing,” said Richie
Cunningham, CEO, Anebulo Pharmaceuticals. “If approved, we believe
selonabant has the potential to offer a much-needed targeted
therapy for rapidly reversing the serious and life-threatening
consequences of accidental cannabis ingestion in children. This
grant aligns with our recent decision to prioritize development of
the intravenous formulation and we look forward to working closely
with NIDA scientific staff on this important program.”
About Selonabant (ANEB-001)
Our lead product candidate is selonabant (ANEB-001), a potent,
small molecule antagonist of CB1, under development to address the
unmet medical need for a specific antidote for cannabis toxicity,
including ACI and unintentional cannabis poisoning. Selonabant is
an orally bioavailable, readily absorbed treatment candidate that
we anticipate will rapidly reverse key symptoms of ACI. Selonabant
is also under development as a parenteral treatment for
unintentional cannabis poisoning. Selonabant is protected by two
issued patents covering various methods of use of the compound and
composition of matter of the crystalline form of selonabant. We
also have multiple pending applications covering various methods of
use of the compound and delivery systems. An observational study in
patients presenting to Emergency Departments with ACI is currently
ongoing. The study will determine concentrations of cannabinoids
and metabolites in plasma and gather information on signs and
symptoms, patients’ disposition and selected subjective
assessments.
About Anebulo Pharmaceuticals, Inc.
Anebulo Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company developing novel solutions for people
suffering from acute cannabinoid intoxication, unintentional
cannabis intoxication and, longer term, for substance use
disorders. Its lead product candidate, selonabant, has completed
dosing in a Phase 2 clinical trial
(www.clinicaltrials.gov/ct2/show/NCT05282797) evaluating its
utility in blocking and reversing the negative effects of acute
cannabinoid intoxication. Selonabant is a competitive antagonist at
the human CB1. For further information about Anebulo, please visit
www.anebulo.com.
Forward-Looking Statements
Statements contained in this press release that are not
statements of historical fact are forward-looking statements as
defined in Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
In some cases, these forward-looking statements can be identified
by words such as "anticipate," "designed," "expect," "may," "will,"
"should" and other comparable terms. Forward-looking statements
include statements regarding the potential use of selonabant as an
emergency treatment of acute cannabis-induced toxicities, including
cannabis-induced CNS depression in children, the grant providing
additional validation of the significant and growing unmet medical
need for an emergency antidote to cannabis, acute cannabis exposure
in children representing a potentially life-threatening condition
that can result in CNS depression, respiratory depression, coma,
and in rare cases death, children being much more sensitive to the
toxic effects of cannabis, pediatric cannabis ingestion resulting
in much more serious outcomes than in adults, and a much greater
risk of hospitalization and admission to intensive care and working
closely with the NIDA scientific staff and the potential of
selonabant to offer a much-needed targeted therapy for rapidly
reversing the serious and life-threatening consequences of
accidental cannabis ingestion in children . You are cautioned that
any such forward-looking statements are not guarantees of future
performance and are subject to a number of risks, uncertainties and
assumptions, including, but not limited to: our ability to pursue
our regulatory strategy, our ability to obtain regulatory approvals
for commercialization of product candidates or to comply with
ongoing regulatory requirements, our ability to obtain or maintain
the capital or grants necessary to fund our research and
development activities, our ability to complete clinical trials on
time and achieve desired results and benefits as expected,
regulatory limitations relating to our ability to promote or
commercialize our product candidates for specific indications,
acceptance of our product candidates in the marketplace and the
successful development, marketing or sale of our products, our
ability to maintain our license agreements, the continued
maintenance and growth of our patent estate and our ability to
retain our key employees or maintain our Nasdaq listing. These
risks should not be construed as exhaustive and should be read
together with the other cautionary statements included in our
Annual Report on Form 10-K for the year ended June 30, 2023, and
our subsequent filings with the SEC, including subsequent periodic
reports on Quarterly Reports on Form 10-Q and Current Reports on
Form 8-K. All forward-looking statements made in this press release
speak only as of the date of this press release and are based on
management's assumptions and estimates as of such date. Except as
required by law, Anebulo undertakes no obligation to update or
revise forward-looking statements to reflect new information,
future events, changed conditions or otherwise after the date of
this press release.
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Anebulo Pharmaceuticals, Inc. Dan George Acting Chief Financial
Officer (512) 598-0931 Dan@anebulo.com
Anebulo Pharmaceuticals (NASDAQ:ANEB)
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