FDA provides favorable input on studies to
support ANEB-001 approval
Part C Extension of Phase 2 trial completed
exploring THC challenge dose of up to 60 mg
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB) (the
“Company” or “Anebulo”), a clinical-stage biopharmaceutical company
developing novel solutions for people suffering from acute
cannabinoid intoxication (ACI) and substance abuse, today announced
positive feedback from the United States Food and Drug
Administration (FDA) following a Type B meeting in July. The FDA
indicated that a single well-controlled study of ANEB-001 in ACI
patients presenting to the emergency department combined with a
larger THC challenge study in volunteers could potentially provide
substantial evidence to support a new drug application.
“We’re very pleased with the encouraging feedback we received
from the FDA as it provides a viable path forward for designing and
executing our Phase 3 trials with ANEB-001. Based on this
constructive guidance and continuing dialog with the FDA, we are
focusing on finalizing our registrational study designs. We look
forward to providing further updates as we continue to advance this
important program,” said Simon Allen, CEO of Anebulo. “We plan to
pursue the development path for ANEB-001 as efficiently as possible
to bring this much-needed treatment for the growing number of
patients who present to emergency departments every day with
cannabinoid-related intoxication.”
In addition to receiving the final minutes of the FDA meeting,
Anebulo has also completed dosing in an open-label Part C extension
of its Phase 2 clinical trial to evaluate the safety and efficacy
of ANEB-001 at higher challenge doses of THC. Twenty healthy adult
volunteers (2 cohorts of 10 subjects) participated in Part C of the
study. Cohort 7 received a single oral dose of 40 mg of THC
together with a single oral dose of 10 mg of ANEB-001. Cohort 8
received a single oral dose of 60 mg of THC together with a single
oral dose of 20 mg of ANEB-001. In the earlier Part B of the study,
a single oral dose of 40 mg THC without ANEB-001 was not well
tolerated due to overt THC-related effects. However, the use of
even higher THC challenge doses was considered acceptable by the
IRB provided that all subjects would also receive ANEB-001. Part C
of the study was therefore conducted as open-label without a
placebo arm.
Subjective and objective assessments performed during the
open-label Part C of the study were similar to those used in Parts
A and B, with the addition of several new outcome measures intended
to explore further evidence of clinically meaningful effects. Based
on preliminary safety observations, THC challenge doses of 40 mg
and 60 mg were well-tolerated when dosed in combination with
ANEB-001, and all treatment-related adverse events were mild and
transient. Full safety, pharmacokinetic (PK), and pharmacodynamic
data from the study, as well as results at higher doses of THC, are
expected in 4Q 2023.
“Part C of this study was designed to provide insight into the
potential efficacy and safety of ANEB-001 in real-world emergency
situations, by challenging subjects with THC doses even higher than
those that could be tested in Parts A and B,” said Ken Cundy,
Ph.D., Chief Scientific Officer of Anebulo. “Higher THC doses in
Part C of this study were administered by ensuring that all healthy
subjects received ANEB-001 concurrently with the THC challenge. We
are pleased to continue our very productive collaboration with our
colleagues at the Centre for Human Drug Research in the Netherlands
and look forward to announcing additional results of this
open-label study.”
In addition to the Part C extension, Anebulo’s observational PK
study in patients reporting to the emergency department with ACI is
currently ongoing. Data gathered from these two studies are
expected to improve our understanding of the range of THC exposures
associated with ACI and the potential for treatment with
ANEB-001.
About the Phase 2 study of ANEB-001
Parts A and B of the Phase 2 study were previously conducted in
the Netherlands by the CHDR. A total of 134 healthy subjects were
enrolled. All subjects received oral THC challenge doses. In total,
91 subjects received single oral doses of ANEB-001. Pharmacodynamic
outcomes were assessed by mixed-effect model repeated measures
analysis of covariance through 8 hours post-ANEB-001 dosing. Safety
was assessed by continuous observation for 24 hours and followed up
at 7 to 14 days after treatment. ANEB-001 was well tolerated in
this study and there were no serious adverse events. At the 30 mg
THC dose, prior to dosing ANEB-001 or placebo, subjects developed
mild to moderate THC-related symptoms including moderate euphoria,
nausea, and/or vomiting, and mild bradyphrenia, dizziness,
paresthesia, and/or feeling emotional. After delayed dosing of 10
mg ANEB-001 or placebo following a 21 mg or 30 mg THC challenge
dose, the adverse events considered possibly or probably related to
ANEB-001 were mild except for one case of moderate nausea/vomiting
at THC doses of 21 mg and 30 mg; the incidence of dizziness and
euphoria was greater in the placebo treated subjects.
Administration of a high-fat meal delayed the absorption of THC
resulting in blunted effects of a 30 mg THC dose on many of the
outcomes. However, delayed dosing of 10 mg ANB-001 still
significantly reduced VAS feeling high in fed subjects (p=0.0030).
Part C of the Phase 2 study was an open-label assessment of higher
THC doses administered simultaneously with ANEB-001. The Dutch
Ethics Committee has allowed these higher THC doses to be
administered to healthy subjects provided that all subjects also
receive treatment with ANEB-001.
About ANEB-001
Our lead product candidate is ANEB-001, a potent, small molecule
cannabinoid receptor antagonist, under development to address the
unmet medical need for a specific antidote for ACI. ANEB-001 is an
orally bioavailable, readily absorbed treatment candidate that we
anticipate will rapidly reverse key symptoms of ACI. ANEB-001 is
protected by one issued patent and rights to one patent application
covering various methods of use of the compound and delivery
systems. We began a Phase 2 proof-of-concept trial for ANEB-001 in
December 2021 in the Netherlands and announced positive Phase 2
Part A proof-of-concept topline data on July 5, 2022, positive Part
B data on September 26, 2022, completed dosing of all subjects in
mid-December 2022, and announced preliminary Phase 2 Part B data on
January 9, 2023. On March 28, 2023, we announced complete results
from Part A and Part B of our Phase 2 clinical trial. We met with
the FDA in July for a Type B meeting to discuss these data and the
potential path forward to approval and received formal minutes on
August 17, 2023. In addition, 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 Acute Cannabinoid Intoxication
Symptoms of ACI can include increased somnolence, impaired
cognition and perception, disorientation, anxiety, and acute
psychosis. A diagnosis of cannabinoid intoxication includes a
recent history of cannabinoid use, and clinically considerable
behavioral or psychological changes, such as anxiety, panic
attacks, euphoria, impaired judgment and motor skills, and elevated
heart rate, which have taken place since cannabinoid exposure.
About Anebulo Pharmaceuticals, Inc.
Anebulo Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company developing novel solutions for people
suffering from acute cannabinoid intoxication and substance abuse
disorder. Its lead product candidate, ANEB-001, 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. ANEB-001 is a competitive antagonist at
the human cannabinoid receptor type 1 (CB1). For further
information about Anebulo, please visit www.anebulo.com.
About The Centre for Human Drug Research
The Centre for Human Drug Research (CHDR), located in Leiden,
the Netherlands, operates as an independent institute that
specializes in early-stage clinical drug research. By merging
groundbreaking methodologies, advanced technologies, and
exceptional facilities, CHDR enables its clients to maximize their
success. CHDR prioritizes the well-being and safety of its
participants while actively contributing to the education of
medical and clinical research communities. For more information
about CHDR, please visit www.chdr.nl.
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 Anebulo's intentions, beliefs,
projections, outlook, analyses or current expectations regarding:
the potential for a single well-controlled study of ANEB-001 in ACI
patients presenting to the emergency department combined with a
larger THC challenge study in volunteers to provide substantial
evidence to support a new drug application; the path forward for
designing and executing Phase 3 trials with ANEB-001 and whether it
is viable and our plans for pursuing Phase 3 development in an
efficient matter; the expected timing for results from the
open-label Part C extension of our Phase 2 clinical trial; the
timing of future updates on the advancement of ANEB-001; future
results that may be implied by prior results; the potential for
ANEB-001 to address an unmet medical need for a specific antidote
for ACI; and Anebulo's expectation that ANEB-001 will rapidly
reverse key symptoms of ACI. 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: initial and interim
results from clinical studies are not necessarily indicative of
results that may be observed in the future; the ability to obtain
regulatory approval; the Type B meeting minutes should not be
relied on as an indication that ANEB-001 will ultimately be
approved; the timing and success of clinical trials and potential
safety and other complications thereof; any negative effects on the
Company's business and product development plans caused by or
associated with health crises or geopolitical issues; and Anebulo's
need for additional capital. These and other risks are described
under the "Risk Factors" heading of Anebulo's Quarterly Report on
Form 10-Q for the quarter ended March 31, 2023, as filed with the
SEC on May 11, 2023. 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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version on businesswire.com: https://www.businesswire.com/news/home/20230821471828/en/
Media Contact Ignacio Guerrero-Ros, Ph.D. Russo Partners
(646) 942-5604 ignacio.guerrero-ros@russopartnersllc.com
Investor Relations Adanna Alexander, Ph.D. or Harrison
Seidner, Ph.D. (646) 942-5603 (646) 942-5599 Adanna@RussoPR.com
Harrison.seidner@russopartnersllc.com
Anebulo Pharmaceuticals, Inc. Sandra Gardiner Acting
Chief Financial Officer (512) 598-0931 Sandra@anebulo.com
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