Clinical-stage biopharmaceutical company Anebulo Pharmaceuticals Inc (Nasdaq:ANEB), a developer of solutions for acute cannabinoid intoxication (ACI) and substance abuse disorders, on Tuesday declared positive topline data from Part A of an ongoing Phase 2 clinical trial evaluating the potential of ANEB-001 to treat ACI.

The study was conducted at the Centre for Human Drug Research (CHDR) in the Netherlands and involved 60 healthy adult occasional cannabis users randomized to three treatment arms.

Part A of the trial was designed to evaluate the effectiveness of a single dose of ANEB-001 in treating healthy subjects challenged with delta-9-tetrahydrocannabinol, better known as THC, the primary psychoactive constituent of cannabis.

According to the company, the initial data demonstrates a highly statistically significant reduction in key symptoms of ACI, with only 10% of subjects in the 50 mg ANEB-001 group and 30% in the 100 mg group reporting feeling high compared to 75% of subjects in the placebo group. ANEB-001 was well tolerated in these healthy volunteers. Also, preliminary safety information showed all adverse events were mild and transient, except in the case of one subject in the 50 mg ANEB-001 group who experienced moderate nausea and vomiting.

Anebulo added that based on the encouraging data from Part A, it plans to initiate Part B of the study at CHDR by the end of third quarter 2022 to evaluate lower doses of ANEB-001. The company is also currently collaborating with the Model-Informed Drug Development (MIDD) group at the US Food and Drug Administration (FDA) to develop a pharmacokinetic/pharmacodynamic (PK/PD) model that will potentially allow prediction of optimal doses for treatment of ACI subjects. Submission of an Investigational New Drug application (IND) for ANEB-001 to initiate US trials is anticipated by the end of 2022.