Anebulo Pharmaceuticals Announces Initiation of Phase 2 Clinical Study Evaluating ANEB-001 for the Treatment of Acute Cannabinoid Intoxication
03 January 2022 - 11:00PM
Business Wire
Affirms expectations for initial topline
results in 1H 2022
Recent FDA pre-IND meeting provides valuable
guidance on U.S. regulatory path; company expects to submit IND in
1Q 2022
Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a
clinical-stage biopharmaceutical company developing novel solutions
for people suffering from acute cannabinoid intoxication and
substance abuse, announces that the first patient has been dosed in
a Phase 2 proof-of-concept clinical study investigating ANEB-001 as
a potential treatment for acute cannabinoid intoxication.
In addition, Anebulo recently held a pre-IND (Investigational
New Drug) meeting with the U.S. Food and Drug Administration (FDA)
during which the company received valuable guidance regarding the
clinical development of ANEB-001 in the U.S. Importantly, the FDA
noted that a challenge model whereby subjects are exposed to THC in
a controlled clinical setting may be acceptable to investigate
primary efficacy, which would allow for the more efficient
development of ANEB-001. Further, the FDA suggested that Anebulo
submit a model-informed drug development (MIDD) paired-meeting
request.
“The initiation of our Phase 2 study in the Netherlands
represents a significant milestone for Anebulo. We continue to
anticipate reporting initial topline results from Part A of this
trial in the first half of 2022, as we closely monitor the impact
of COVID-19. Despite the recently announced national lockdown in
the Netherlands, our CRO is continuing to screen and enroll
patients,” stated Daniel Schneeberger, M.D., Chief Executive
Officer of Anebulo.
“Additionally, we are pleased with the guidance provided by the
FDA regarding ANEB-001’s clinical and regulatory path in the U.S.
We were able to rapidly incorporate the FDA’s feedback into the
design of the current Phase 2 trial to make the data generated in
Europe as relevant as possible for a potential future NDA
submission. We expect to file an IND with the FDA during the first
quarter of 2022,” he added. “There is a large and growing need to
treat acute cannabinoid intoxication with 1.7 million
cannabinoid-related emergency department visits in the U.S. in
2018, and we believe ANEB-001 holds potential to reverse symptoms
safely and rapidly.”
The Phase 2 clinical trial is a randomized, double-blind,
placebo-controlled study at a single site in the Netherlands to
evaluate ANEB-001 in the inhibition of THC-induced effects. The new
trial design anticipates enrolling a total of 60 patients in Part
A, randomized 1:1:1 between 50mg of ANEB-001, 100mg of ANEB-001 and
placebo. All participants will receive 10.5mg of THC as a challenge
drug. The goal of Part A is to deliver clinical proof-of-concept
that ANEB-001 can reverse the effects of THC. Part B will enroll
additional cohorts and further explore the relationship between THC
and ANEB-001 dose levels and clinical efficacy, and provide
additional datapoints for pharmacokinetic/pharmacodynamic models.
Anebulo believes the ability to quickly adapt the protocol and test
additional hypotheses will save time and reduce development risk
while designing future trials in 2022.
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.
Its lead product candidate, ANEB-001, is intended to reverse 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) with good oral
bioavailability and brain penetration (rat brain:plasma ratio of
approximately 1.5). Clinical trials completed to date have shown
that ANEB-001 is rapidly absorbed, well tolerated, and may lead to
weight loss, an effect that is consistent with CB1 antagonism in
the central nervous system. 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 Pharmaceuticals and
members of its management, as well as the assumptions on which such
statements are based. Prospective investors are cautioned that any
such forward-looking statements are not guarantees of future
performance and involve risks and uncertainties, including risks
attendant to developing, testing and commercializing the company’s
product candidates, and those described in Anebulo Pharmaceutical’s
most recent annual report on Form 10-K 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
Pharmaceuticals undertakes no obligation to update or revise
forward-looking statements to reflect changed conditions.
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version on businesswire.com: https://www.businesswire.com/news/home/20220103005125/en/
Anebulo Pharmaceuticals, Inc. Rex Merchant Chief
Financial Officer (512) 598-0931 IR@anebulo.com
LHA Investor Relations Yvonne Briggs (310) 691-7100
ybriggs@lhai.com
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