Anebulo Pharmaceuticals Announces Completion of Dosing and Preliminary Data from Part B of its Phase 2 Study of ANEB-001 for Acute Cannabinoid Intoxication
- 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
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
The Phase 2 study was conducted in
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
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
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
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
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Scott Anderson
Head of Investor Relations and Public Relations
(858) 229-7063
scott@anebulo.com
Chief Financial Officer
(512) 598-0931
IR@anebulo.com
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