Anebulo Pharmaceuticals, Inc. 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.

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. ANEB-001 the 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 company 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. Company 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.