Anebulo Pharmaceuticals Wins NIDA Grant for Cannabis Toxicity IV Treatment

Anebulo Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company listed on Nasdaq under the ticker ANEB, has secured the initial installment of a two-year cooperative grant from the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH). The total grant, which could reach approximately $1.9 million, is intended to support the development of selonabant, an intravenous treatment aimed at managing acute cannabis-induced toxicities, particularly central nervous system (CNS) depression in children. The first part of the grant amounts to $0.9 million, with the remaining $1 million contingent on certain milestones. This funding was granted under NIH award number 1U01DA059995-01.

Ken Cundy, Chief Scientific Officer at Anebulo Pharmaceuticals, expressed gratitude for the grant, underscoring its importance in addressing the urgent medical need for an antidote to cannabis toxicity. He elaborated on the severe effects of acute cannabis exposure in children, which can lead to CNS and respiratory depression, coma, and even death in rare cases. Cundy noted that children are particularly vulnerable due to their underdeveloped endocannabinoid systems, which contain a higher number of primary cannabinoid receptor type 1 (CB1) receptors, making them more susceptible to the adverse effects of cannabis. Consequently, incidents of pediatric cannabis ingestion often result in more severe outcomes and an increased likelihood of hospitalization and intensive care.

Richie Cunningham, CEO of Anebulo Pharmaceuticals, highlighted that the grant from NIDA validates the progress made in the company's research, particularly following a successful Phase 2 proof-of-concept study involving oral selonabant. He emphasized the potential of selonabant to serve as a targeted emergency treatment for the serious and potentially life-threatening consequences of accidental cannabis ingestion in children. Cunningham also mentioned that the grant aligns with Anebulo's strategy to prioritize the development of an intravenous formulation of selonabant, and the company looks forward to collaborating closely with NIDA's scientific staff on this critical initiative.

Selonabant, Anebulo's leading product candidate, is a potent, small molecule antagonist of the CB1 receptor, designed to counteract the toxic effects of cannabis. It is being developed as both an oral and a parenteral (intravenous) treatment to quickly reverse key symptoms of acute cannabinoid intoxication (ACI) and unintentional cannabis poisoning. The drug is protected by two issued patents, which cover various methods of use and the composition of matter of its crystalline form, with additional pending applications related to its methods of use and delivery systems. An observational study is currently underway to evaluate cannabinoid and metabolite concentrations in patients presenting with ACI in emergency departments, gathering data on symptoms, patient outcomes, and subjective assessments.

Anebulo Pharmaceuticals is dedicated to developing innovative solutions for acute cannabinoid intoxication, unintentional cannabis intoxication, and long-term substance use disorders. The company’s research and development efforts are focused on selonabant, which has shown promise in a Phase 2 clinical trial for mitigating the adverse effects of acute cannabinoid intoxication. According to clinical trial records, the company is evaluating the drug's efficacy in blocking and reversing these negative effects.

Anebulo remains committed to advancing its research and development initiatives to address the significant and growing unmet medical need for effective treatments for cannabis toxicity, particularly in vulnerable populations such as children.