5 July 2022 - - US-based biopharmaceutical company Anebulo Pharmaceuticals, Inc. (NASDAQ: ANEB) has posted positive topline data from Part A of an ongoing Phase 2 clinical trial evaluating the potential of ANEB-001 to treat ACI, the company said.

Part A was a 60 subject randomized, double-blind, placebo-controlled trial 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.

These data demonstrated 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 (p < 0.001). ANEB-001 was well tolerated in these healthy volunteers.

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.

The study was conducted at the Centre for Human Drug Research in the Netherlands and enrolled 60 healthy adult occasional cannabis users randomized to three treatment arms of 20 subjects per arm.

All subjects were challenged with a single oral dose of 10.5 mg THC and then treated with single oral doses of 50 mg ANEB-001, 100 mg ANEB-001, or placebo. Subjects were monitored for 24 hours to assess safety, tolerability, and pharmacokinetics, and repeatedly tested to determine potential effects on endpoints related to ACI symptoms.

The tests also included a series of validated measures of subjective CNS symptoms using visual analog scale assessments, as well as objective measures of intoxication. Subjects challenged with THC and treated with placebo showed substantial CNS effects including feeling high, decreased alertness, increased body sway, and increased heart rate.

Compared to placebo, treatment of subjects with ANEB-001 led to a significant, robust, and sustained reduction in the VAS feeling high score (p < 0.0001 at both dose levels) and improvement in the VAS alertness scale (p < 0.01).

In addition, the proportion of subjects reporting feeling high on the VAS was significantly reduced by ANEB-001 (p < 0.001).

Although THC-induced effects on body sway and heart rate in this study were small, there was also a trend towards statistical improvement of these parameters with ANEB-001 treatment compared to placebo.

The 50 mg and 100 mg doses had similar results, suggesting that lower doses should be explored. Pharmacokinetic data are pending and additional analyses of Part A data, including pharmacokinetic/pharmacodynamic (PK/PD) correlations, are planned.

Based on the encouraging data from Part A, the company plans to initiate Part B of the study at CHDR by the end of 3Q22 to evaluate lower doses of ANEB-001.

Anebulo is currently collaborating with the Model-Informed Drug Development group at FDA to develop a PK/PD model that will potentially allow prediction of 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. Submission of an Investigational New Drug application for ANEB-001 to initiate US trials is anticipated by the end of 2022.