Acute Cannabinoid Intoxication: This Pharma Company's Clinical Trials To Reduce And Treat Symptoms

Anebulo Pharmaceuticals, Inc. ANEB, a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication (ACI) and substance addiction, announced the 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.

“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 Simon Allen, CEO of Anebulo.

ANEB-001 Clinical Trial: Conducted in the Netherlands by the Centre for Human Drug Research, parts A and B of the Phase 2 study enrolled 134 healthy adults.

"Part B of the Phase 2 trial was an adaptive design that included six cohorts of up to 15 healthy subjects to examine different doses of THC and ANEB-001, and the impact of delayed dosing of ANEB-001 or placebo," according to the news release. “We successfully demonstrated rapid reversal of key ACI symptoms even after a one-hour delay between the THC challenge and ANEB-001 dosing.” 

Data from the study's part A 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. But 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 a matching placebo.

Preliminary Results

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 essential psychotropic effects of THC doses as high as 30 mg, including a reduction in feeling high and improvement in alertness and body sway. “We believe the final data from this study, together with data from our planned observational study in ACI subjects, will support the design of a registrational trial," Allen said.

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, according to a company press release.

"We anticipate discussing the final data from this study with FDA at the end of Phase 2A meeting in the first half of this year,” Allen concluded. Final analyses await the unblinded data expected by end of 1Q2023.

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Photo: Courtesy Of CDC On Unsplash