- ANEB-001 statistically significantly reduced VAS Feeling
High in all cohorts (p=<0.0001 at the 30 mg THC dose
level)
- A single 10 mg oral dose of ANEB-001 reduced key symptoms of
Accute Cannabinoid Intoxication induced in healthy volunteers by 30
mg challenge dose of oral THC
- Delayed dosing of ANEB-001 rapidly reversed pre-existing THC
effects
- ANEB-001 was well tolerated
- Targeting End of Phase 2A (EOP2A) meeting with FDA by mid
2023
AUSTIN,
Texas, March 28, 2023 /PRNewswire/ -- 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 addiction, today announced
complete results from its randomized, double-blind,
placebo-controlled Phase 2 clinical trial evaluating ANEB-001 as a
potential treatment for ACI in healthy volunteers challenged with
oral delta-9-tetrahydrocannabinol ("THC"). Part B of the study was
an adaptive design that included six cohorts of up to 15 healthy
adults to examine different doses of THC and ANEB-001, and the
impact of delayed dosing of ANEB-001 or placebo. In total, Parts A
and B of the Phase 2 study enrolled 134 healthy subjects.
"The positive results of the Phase 2 proof of concept study are
very encouraging and will have significant clinical implications
for the unmet need of patients presenting to emergency departments
with ACI," said Simon Allen, Chief
Executive Officer of Anebulo. "We believe the complete data from
this study, together with data from our observational study in ACI
subjects and our PK/PD modeling efforts, will provide support for
the design of a registrational trial. We are in the process of
requesting an End of Phase 2A meeting with FDA to discuss the final
data from this study. We expect the meeting to occur within 75 days
from the date of the request but acknowledge that it could be
longer."
Final ANEB-001 Part 2 Proof of Concept Study Results
Data from Part A of the study previously showed positive
protective effects of a single oral dose of 50 or 100 mg ANEB-001
when co-administered with an oral challenge dose of 10.5 mg THC. In
Part B of the study, subjects were challenged with substantially
higher oral doses of THC (21, 30, or 40 mg) and treated with lower
doses of ANEB-001 (10 or 30 mg) or a matching placebo. Delayed
dosing of ANEB-001 was also examined by introducing a one-hour
pause between the THC challenge and treatment with the ANEB-001 or
placebo. The final cohort of the study included the administration
of a high-fat meal prior to the THC challenge.
Based on the final data for Part B of the study, a single low
oral dose of ANEB-001 (10 mg) administered 1 hour after a THC
challenge rapidly and statistically significantly reversed key
psychotropic effects of THC doses as high as 30 mg, including a
reduction in the visual analog scale (VAS) for feeling high
(p=<0.0001) and improvement in VAS alertness (p=0.0042) and
reduced body sway (p=0.0196). In a pre-specified pooled analysis of
data for the combined 21 mg or 30 mg THC dose levels, a single 10
mg of ANEB-001 administered one hour after THC achieved statistical
significance on all primary outcomes, including a reduction in VAS
feeling high (p=<0.0001), improvement in VAS alertness
(p=0.0024), reduced body sway (p=0.0014), and reduction in heart
rate (p=0.0125). ANEB-001 also reduced the time required for the
THC effects to normalize back to baseline.
"With these final data from the Phase 2 proof of concept study
we have shown favorable tolerability and efficacy data of ANEB-001
in rapidly reversing the effects of a THC challenge, reinforcing
the preliminary data previously reported," said Ken Cundy, Ph.D., Chief Scientific Officer of
Anebulo. "These positive data showed that delayed ANEB-001
treatment after a THC challenge produced statistically significant
improvements in all key outcomes, as well as improvements in other
exploratory outcomes, demonstrating the therapeutic potential of
ANEB-001 for the treatment of ACI. This successful study is the
result of the hard work of the Anebulo team and our colleagues at
the Centre for Human Drug Research ("CHDR") in the Netherlands. We look forward to presenting
additional details from the study at a future scientific
meeting."
The Phase 2 study was 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 (MMRM) analysis of covariance (ANCOVA) through 8
hours post-ANEB-001 dosing. Safety was assessed by continuous
observation through 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).
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 a
Phase 2 clinical trial (NCT05282797) evaluating its utility in
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 and follow us on LinkedIn.
About ANEB-001
Our lead product candidate is ANEB-001, a potent, small molecule
cannabinoid receptor antagonist, 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,
announced preliminary Phase 2 Part B data on January 9, 2023, and announced complete Phase 2
data on March 28, 2023.
About Acute Cannabinoid Intoxication
Symptoms of ACI can include increased somnolence, impaired
cognition and perception, disorientation, anxiety, and acute
psychosis. According to DSM-5, a diagnosis of cannabinoid
intoxication should include a recent history of cannabinoid use,
and clinically considerable behavioral or psychological changes,
such as euphoria, impaired judgment and motor skills, which have
taken place since cannabinoid exposure.
About the Centre for Human Drug Research
The CHDR is an independent institute that specializes in
cutting-edge early-stage clinical drug research. Combining
innovative methods and technologies, state-of-the-art facilities,
and talented, motivated researchers helps CHDR maximize its
clients' success. In addition, CHDR places the highest priority on
their subjects' comfort and safety, and they play an active role in
helping educate the medical and clinical research communities.
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," "believe," "targeting," "expect,"
"will," "should" and other comparable terms. Forward-looking
statements include statements regarding Anebulo's intentions,
beliefs, projections, outlook, analyses or current expectations
regarding: the targeted timing for an End of Phase 2A meeting with
the FDA by mid 2023; the expected timing for a response from the
FDA on the request for an End of Phase 2A meeting; the timing for
presenting further details of the Phase 2 clinical trial; the
potential for ANEB-0001 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; clinical trial site
challenges that may impact the expected timing of the Company's
ongoing clinical trials; the timing and success of clinical trials
and potential safety and other complications thereof; 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 December 31,
2022, as filed with the SEC on February 10, 2023, and other filings Anebulo
makes with the Securities and Exchange Commission from time to time
(which are available at http://www.sec.gov). 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.
Media Contact
Ignacio Guerrero-Ros, Ph.D.
Russo Partners
646-942-5604
ignacio.guerrero-ros@russopartnersllc.com
Investor Contact
Adanna
Alexander, Ph.D.
Russo Partners
646-942-5603
adanna.alexander@russopartnersllc.com
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