Suffering From Acute Cannabinoid Intoxication? Anebulo Is Getting Closer To Investigational New Drug Application

Anebulo Pharmaceuticals, Inc. ANEB revealed positive topline data from part A of an ongoing Phase 2 clinical trial evaluating the potential of ANEB-001 to treat acute cannabinoid intoxication (ACI).

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.

“We believe this proof-of-concept trial demonstrates ANEB-001’s potential to reverse the symptoms of ACI for many of the five thousand cannabinoid intoxicated individuals visiting our emergency departments in the United States on a daily basis,” stated Simon Allen, CEO of Anebulo. “We believe marijuana legalization and greater consumer access to cheaper and higher potency THC products will continue to increase the incidence and severity of emergency department visits related to cannabinoid intoxication. With no FDA approved therapy, individuals intoxicated with cannabinoids have few treatment options and may require expensive follow-on interventions for neuropsychiatric complications such as anxiety and acute psychosis. ANEB-001 has the potential to mitigate these unfortunate circumstances and reduce their burden on individuals, society, and our healthcare system.”

Based on the encouraging data from Part A, the company plans to initiate Part B of the study at CHDR by the end of third quarter 2022 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 U.S. trials is anticipated by the end of 2022.

Photo by Louis Reed on Unsplash

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