Anebulo Receives Positive Feedback from FDA on Path to Advance Phase 3 Clinical Development of ANEB-001 and Completes Dosing of Phase 2 Extension
- Positive feedback received from FDA for a new drug application
- Preliminary safety observations show well-tolerance of ANEB-001 with THC challenge doses of 40 mg and 60 mg
- None.
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
“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
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
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
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,
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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Source: Anebulo Pharmaceuticals, Inc.