Anebulo Pharmaceuticals has initiated dosing in its Phase I single ascending dose trial of intravenous selonabant, marking a significant step toward developing the first emergency antidote for acute cannabis-induced toxicity. The randomized, double-blind, placebo-controlled study is examining the safety, tolerability, and pharmacokinetics of IV selonabant in healthy adult participants aged 18 to 25 years, with funding support from the National Institute on Drug Abuse and National Institutes of Health under award number U01DA059995.
Targeting Critical Pediatric Need
The IV formulation represents a strategic pivot toward addressing acute cannabis toxicity in pediatric patients, a condition CEO Richie Cunningham describes as having "serious and potentially life-threatening consequences, including CNS depression, respiratory depression, coma, and in rare cases death." Research indicates children demonstrate heightened sensitivity to cannabis toxic effects due to age-related differences in cannabis receptor abundance and distribution in their brains, resulting in more serious outcomes than adults and greater risk of hospitalization and intensive care admission.
"This important milestone brings Anebulo closer to its goal of providing the first emergency antidote for acute cannabis-induced toxicity," Cunningham stated. The company has prioritized the IV formulation development as a potential treatment for pediatric subjects experiencing acute cannabis-induced toxicity, believing it represents a more serious condition offering faster approval timelines relative to adult oral products.
Strong Phase II Foundation
Selonabant, a CB1 receptor competitive antagonist, previously demonstrated promising efficacy in Anebulo's Phase II oral trial. The CB1 receptor serves as the primary target implicated in cannabis psychotropic effects, including feelings of being high, anxiety, and impaired motor function associated with tetrahydrocannabinol consumption.
In the prior Phase II study, a single dose of oral selonabant nearly completely blocked typical subjective effects of THC, including altered alertness and euphoric sensations, in healthy adults challenged with oral THC. The drug effectively blocked THC effects across the tested dose range while maintaining a generally safe profile with no serious adverse events reported.
The most common adverse effects included nausea, vomiting, and hyperhidrosis, which were dose-dependent and absent at the efficacious 10 mg dose level. This safety and efficacy profile provided the foundation for advancing to IV formulation development.
Regulatory Support and Market Need
FDA interactions have reinforced Anebulo's assessment of significant and growing unmet medical need for pediatric cannabis toxicity treatments. The regulatory agency has suggested close collaboration with Anebulo to facilitate selonabant development for this pediatric indication.
"FDA has suggested a close collaboration with Anebulo to facilitate development of selonabant for this important pediatric condition," Cunningham noted. "If approved, we believe selonabant has the potential to offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of acute cannabis-induced toxicity in children."
The Phase I study continues enrollment as Anebulo advances toward its goal of providing the first emergency antidote specifically designed for acute cannabis-induced toxicity, addressing a critical gap in emergency medicine treatment options.
