- Study Met Primary Endpoint VAS Feeling High (p <
0.0001)
- Statistically Significant and Sustained Reductions in Key
THC-Related CNS Symptoms
- Conference Call 8:30am Eastern Time Today
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a
clinical-stage biopharmaceutical company developing novel solutions
for people suffering from acute cannabinoid intoxication (ACI) and
substance abuse disorders (the “Company” or “Anebulo”), today
announced positive topline data from Part A of an ongoing Phase 2
clinical trial evaluating the potential of ANEB-001 to treat ACI.
Part A was a 60 subject randomized, double-blind,
placebo-controlled trial designed to evaluate the effectiveness of
a single dose of ANEB-001 in treating healthy subjects challenged
with delta-9-tetrahydrocannabinol, better known as THC, the primary
psychoactive constituent of cannabis. These data demonstrated a
highly statistically significant reduction in key symptoms of ACI,
with only 10% of subjects in the 50 mg ANEB-001 group and 30% in
the 100 mg group reporting feeling high compared to 75% of subjects
in the placebo group (p < 0.001). ANEB-001 was well tolerated in
these healthy volunteers. Preliminary safety information showed all
adverse events were mild and transient, except in the case of one
subject in the 50 mg ANEB-001 group who experienced moderate nausea
and vomiting.
“We believe this proof-of-concept trial demonstrates ANEB-001’s
potential to reverse the symptoms of ACI for many of the five
thousand cannabinoid intoxicated individuals visiting our emergency
departments in the United States on a daily basis,” said Simon
Allen, Chief Executive Officer of Anebulo. “We believe marijuana
legalization and greater consumer access to cheaper and higher
potency THC products will continue to increase the incidence and
severity of emergency department visits related to cannabinoid
intoxication. With no FDA approved therapy, individuals intoxicated
with cannabinoids have few treatment options and may require
expensive follow-on interventions for neuropsychiatric
complications such as anxiety and acute psychosis. ANEB-001 has the
potential to mitigate these unfortunate circumstances and reduce
their burden on individuals, society, and our healthcare
system.”
The study was conducted at the Centre for Human Drug Research
(CHDR) in the Netherlands and enrolled 60 healthy adult occasional
cannabis users randomized to three treatment arms of 20 subjects
per arm. All subjects were challenged with a single oral dose of
10.5 mg THC and then treated with single oral doses of 50 mg
ANEB-001, 100 mg ANEB-001, or placebo. Subjects were monitored for
24 hours to assess safety, tolerability, and pharmacokinetics, and
repeatedly tested to determine potential effects on endpoints
related to ACI symptoms. The tests also included a series of
validated measures of subjective CNS symptoms using visual analog
scale (VAS) assessments, as well as objective measures of
intoxication. Subjects challenged with THC and treated with placebo
showed substantial CNS effects including feeling high, decreased
alertness, increased body sway, and increased heart rate. Compared
to placebo, treatment of subjects with ANEB-001 led to a
significant, robust, and sustained reduction in the VAS feeling
high score (p < 0.0001 at both dose levels) and improvement in
the VAS alertness scale (p < 0.01). In addition, the proportion
of subjects reporting feeling high on the VAS was significantly
reduced by ANEB-001 (p < 0.001). Although THC-induced effects on
body sway and heart rate in this study were small, there was also a
trend towards statistical improvement of these parameters with
ANEB-001 treatment compared to placebo. The 50 mg and 100 mg doses
had similar results, suggesting that lower doses should be
explored. Pharmacokinetic data are pending and additional analyses
of Part A data, including pharmacokinetic/pharmacodynamic (PK/PD)
correlations, are planned.
“The number of individuals with cannabinoid related intoxication
visiting our emergency departments is clearly on the rise,” said
Dr. Andrew Monte M.D., Ph.D., Professor of Emergency Medicine &
Medical Toxicology, University of Colorado Denver-Anschutz Medical
Center. “Patients are coming from multiple settings including
first-time users taking small doses of THC, adults and children
inadvertently ingesting powerful THC gummies, and regular users
unintentionally overdosing on new and more powerful THC products.
Introducing an effective cannabinoid antidote into our treatment
options would represent a significant improvement in how we can
manage these patients”
Based on the encouraging data from Part A, the Company plans to
initiate Part B of the study at CHDR by the end of third quarter
2022 to evaluate lower doses of ANEB-001. Anebulo is currently
collaborating with the Model-Informed Drug Development (MIDD) group
at FDA to develop a PK/PD model that will potentially allow
prediction of optimal doses for treatment of ACI subjects.
Preparations are ongoing for an observational study in ACI subjects
in the emergency department setting to further support the PK/PD
model and ANEB-001 development. Submission of an Investigational
New Drug application (IND) for ANEB-001 to initiate U.S. trials is
anticipated by the end of 2022.
Conference Call and Webcast
Anebulo will host a conference call and webcast today, July 5,
2022, at 8:30 am Eastern Time to discuss topline data from the
ANEB-001 Phase 2 Part A Proof-of-Concept clinical trial. To access
the audio webcast with slides, please visit the “Events &
Presentations” page in the Investors & Media section of the
Company’s website at
https://ir.anebulo.com/company-information/presentations. The call
can also be accessed by dialing (877) 407-8815 (domestic) or +1
(201) 689-8025 (international) with conference ID 13731361.
For those unable to participate in the conference call or
webcast, a replay will be available on the Company’s website.
About Visual Analogue Scale (VAS)
VAS is a tool used to help rate the intensity of certain
sensations and feelings, such as feeling high. The visual analog
scale is typically a straight line with one end meaning not high
and the other end meaning extremely high. A patient marks a point
on the line that matches how high they feel.
About Acute Cannabinoid Intoxication (ACI)
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 CHDR
The Centre for Human Drug Research (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, is currently in a
Phase 2 clinical trial
(www.clinicaltrials.gov/ct2/show/NCT05282797) to evaluate its
utility in reversing the negative effects of acute cannabinoid
intoxication within one hour of administration. 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
This press release contains 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.
These forward-looking statements, along with terms such as
“anticipate,” “expect,” “intend,” “may,” “will,” “should” and other
comparable terms, involve risks and uncertainties because they
relate to events and depend on circumstances that will occur in the
future. Those statements include statements regarding the intent,
belief or current expectations of Anebulo and members of its
management, as well as the assumptions on which such statements are
based. These forward-looking statements include, but are not
limited to, those regarding: ANEB-001’s potential to reverse the
symptoms of ACI for many of the five thousand cannabinoid
intoxicated individuals visiting our emergency departments in the
United States on a daily basis; the belief that marijuana
legalization and greater access to cheaper and higher potency THC
products will continue to increase the incidence and severity of
emergency department visits related to cannabinoid intoxication;
the possibility that individuals intoxicated with cannabinoids may
require expensive follow-on interventions for neuropsychiatric
complications such as anxiety and acute psychosis; ANEB-001’s
potential to mitigate these unfortunate circumstances and reduce
their burden on individuals, society, and our healthcare system;
the Company’s plans to conduct additional analysis of Part A data,
including PK/PD correlations; the Company’s plans to initiate Part
B of the study and the design, progress and expected timing
thereof; the Company’s plans to develop a PK/PD model and the
potential thereof to predict optimal doses for treatment of ACI
subjects; the Company’s plans with respect to an observational
study in ACI subjects in the emergency department; and the
Company’s intention to submit an IND and the expected timing
thereof. Prospective investors 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: there is no guarantee
that the Company’s planned IND for ANEB-001 will be cleared by the
FDA; initial 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, commercialization and
product development plans caused by or associated with COVID-19 or
geopolitical issues; and those described in Anebulo’s most recent
annual report on Form 10-K filed with the Securities and Exchange
Commission (SEC) on September 22, 2021 and in other periodic
reports filed with the SEC, and that actual results may differ
materially from those contemplated by such forward-looking
statements. Except as required by federal securities law, Anebulo
undertakes no obligation to update or revise forward-looking
statements to reflect changed conditions.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220705005289/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
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