Anebulo Pharmaceuticals (NASDAQ: ANEB) has announced first patients dosed in its Phase 1 single ascending dose (SAD) study intravenous selonabant—under development for acute cannabis-induced (ACI) toxicity—in healthy young adults.
The company reports that the study is supported by a collaborative grant of $994,300 awarded by the National Institute on Drug Abuse (NIDA).
Richie Cunningham, CEO of Anebulo, commented, “This important milestone brings Anebulo closer to its goal of providing the first emergency antidote for acute cannabis-induced toxicity. Anebulo previously evaluated selonabant as an oral treatment in a Phase 2 clinical trial, demonstrating potential for blocking and reversing the negative effects of ACI in healthy adults challenged with oral THC. The company has since prioritized the advancement of a selonabant IV formulation as a potential treatment for pediatric patients with ACI toxicity, which it believes is a more serious condition that offers the potential for a faster timeline to approval relative to the adult oral product. In particular, acute cannabis exposure in children can result in serious and potentially life-threatening consequences, including CNS depression, respiratory depression, coma, and in rare cases death. Research has shown that children are much more sensitive to the toxic effects of cannabis, due in part to age-related differences in the abundance and distribution of cannabis receptors in their brains. As a consequence, cannabis ingestion in children can result in much more serious outcomes than in adults, and a much greater risk of hospitalization and admission to intensive care.”
Mr. Cunningham added, “In addition to the continuing support from NIDA, our interactions with the FDA have confirmed our belief that there is a significant and growing unmet need for a treatment for children exposed to cannabis toxicity. FDA has suggested a close collaboration with Anebulo to facilitate development of selonabant for this important pediatric condition. 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 ACI toxicity in children.”
