- Preliminary data showed ANEB-001 reduced effects of a 30 mg
dose of THC
- Delayed dosing of ANEB-001 rapidly reversed pre-existing THC
effects
- Full PK, PD, and safety data expected by end of
1Q2023
- Company targeting an End of Phase 2A meeting with FDA in the
first half of 2023
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a
clinical-stage biopharmaceutical company developing novel solutions
for people suffering from acute cannabinoid intoxication (“ACI”)
and substance addiction (the “Company” or “Anebulo”), today
announced completion of dosing in its randomized, double-blind,
placebo-controlled Phase 2 clinical trial evaluating ANEB-001 as a
potential treatment for ACI in healthy subjects challenged with
oral THC. Part B of the Phase 2 trial 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.
Data from Part A of the study 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 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 administration of a high fat meal prior to the THC
challenge. Additional analyses await the final unblinded data.
Based on preliminary pharmacodynamic data for Part B of the
study, a single low oral dose of ANEB-001 (10 mg) administered 1
hour after THC appeared to rapidly reverse key psychotropic effects
of THC doses as high as 30 mg, including reduction in feeling high
and improvement in alertness and body sway. ANEB-001 also appeared
to reduce the time required for effects to normalize back to
baseline. Only 5 subjects were challenged with 40 mg THC due to
poor THC tolerability. Final analyses await the unblinded data
expected by end of 1Q2023.
“Completing the dosing in this Phase 2 trial represents an
important milestone for the company. Preliminary data showed that a
single 10 mg dose of ANEB-001 reduced key symptoms of ACI induced
with 30 mg of THC,” said Simon Allen, Chief Executive Officer of
Anebulo. “Further, we successfully demonstrated rapid reversal of
key ACI symptoms even after a one-hour delay between the THC
challenge and ANEB-001 dosing. We believe the final data from this
study, together with data from our planned observational study in
ACI subjects, will provide support for the design of a
registrational trial. We anticipate discussing the final data from
this study with FDA at an End of Phase 2A meeting in the first half
of this year.”
The Phase 2 study was conducted in the Netherlands by the Centre
for Human Drug Research (“CHDR”). A total of 134 healthy subjects
were enrolled. The safety data for the study are still blinded.
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 euphoria, bradyphrenia, paresthesia,
and feeling emotional. After dosing ANEB-001 or placebo, the
adverse events considered possibly or probably related to ANEB-001,
THC, or placebo were mild except for one case of moderate
nausea/vomiting. Administration of a high fat meal delayed the THC
effects and the reversal of feeling high by ANEB-001.
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, and completed dosing of all subjects
in mid-December 2022.
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 recent history of cannabinoid use,
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 their
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.
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 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.
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,” “designed,” “expect,”
“intend,” “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 Phase 2 Study for ANEB-001 and the
design, timing and potential benefits thereof; expected timing for
full PK, PD and safety data from Anebulo’s Phase 2 Study of
ANEB-001 by the end of the first quarter of 2023; the targeted
timing for an End of Phase 2A meeting with the FDA in the first
half of 2023; future results that may be implied by prior results;
Anebulo’s belief that the data from its Phase 2 Study of ANEB-001,
together with data from its planned observational study in ACI
subjects, will provide support for the design of a registrational
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, including
challenges related to the ongoing COVID-19 pandemic; 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
COVID-19 or geopolitical issues; and Anebulo’s need for additional
capital. These and other risks are described under the “Risk
Factors” heading of Anebulo’s most recent quarterly report on Form
10-Q filed with the Securities and Exchange Commission on November
10, 2022. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230109005343/en/
Anebulo Pharmaceuticals, Inc. Scott Anderson Head of
Investor Relations and Public Relations (858) 229-7063
scott@anebulo.com
Rex Merchant Chief Financial Officer (512) 598-0931
IR@anebulo.com
Anebulo Pharmaceuticals (NASDAQ:ANEB)
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