Anebulo Pharmaceuticals, Inc. announced positive interim data from the first two cohorts of Part B of its ongoing Phase 2 clinical trial evaluating ANEB-001 as a treatment for ACI. The first two cohorts were challenged with 21 mg of THC, dosed orally (twice the THC dose used in Part A). Subjects then received 30mg (cohort 1) or 10mg (cohort 2) oral doses of ANEB-001, or matching placebo. The interim data available from Part B include pharmacokinetics, key pharmacodynamic outcomes, and blinded safety data. Based on these data, subjects challenged with a higher 21 mg oral THC dose and treated with placebo showed greater central nervous system (CNS) effects than observed in Part A with 10.5 mg THC. The effects included a substantial increase in feeling high and body sway, decreased alertness, and slightly increased heart rate compared to baseline. In contrast, treatment of subjects with 10 mg or 30 mg ANEB-001 led to significant and sustained reductions in the visual analog scale (VAS) feeling high score (p < 0.001), improvement in the VAS alertness scale (p < 0.01), and a reduction in THC-induced body sway (p < 0.01), compared to placebo. In addition, 100% of subjects given 21 mg THC with placebo in Cohorts 1 and 2 met the VAS threshold for feeling high (>20 mm on the 100 mm VAS scale) compared to only 1 subject per group treated with ANEB-001 at 10 mg or 30 mg doses. Although the THC-induced increase in heart rate in this study was small, there was a trend towards improvement with ANEB-001 compared to placebo. The 10 mg and 30 mg ANEB-001 doses had similar effects to previous higher doses used in Part A, despite doubling the THC dose. Pharmacokinetic data from Part A and the first two cohorts of Part B confirmed rapid absorption and dose-related plasma exposure for oral ANEB-001. The Phase 2 study is being conducted in healthy adult occasional cannabis users at the Centre for Human Drug Research (CHDR) in the Netherlands. Results of Part A of the study, announced in July 2022, showed positive effects of 50 mg or 100 mg of ANEB-001 in reducing the effects of a 10.5 mg oral THC dose. Part B of the study is an adaptive study design intended to evaluate lower doses of ANEB-001 at higher levels of THC. The company intends to enroll a total of at least 6 cohorts in Part B, with up to 15 subjects per cohort, randomized 2:1 to active versus placebo. Based on Part A and interim Part B results, the Company is continuing Part B of the study at CHDR to further evaluate
the dose response and the effects of separating the doses of THC and ANEB-001. Enrollment of the third cohort of Part B is ongoing. Anebulo is currently collaborating with the Model-Informed Drug Development (MIDD) group at FDA to develop a PK/PD model that will be designed to predict optimal doses for treatment of ACI subjects. Preparations are ongoing for an observational study in ACI subjects in the emergency department setting to further support the PK/PD model and ANEB- 001 development. Based on blinded safety data, adverse events in Cohorts 1 and 2 were mild and transient, except for two cases of moderate dizziness in Cohort 1 likely attributable to THC.