Anebulo Pharmaceuticals has started dosing participants in its Phase I single ascending dose (SAD) trial of intravenous (IV) selonabant, an antidote targeting acute cannabis-induced toxicity.
The study is funded through a collaborative grant provided by the National Institute on Drug Abuse (NIDA).
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Anebulo CEO Richie Cunningham said: “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 II clinical trial, demonstrating potential for blocking and reversing the negative effects of acute cannabinoid intoxication (ACI) in healthy adults challenged with oral tetrahydrocannabinol (THC).
“The company has since prioritised the advancement of a selonabant IV formulation as a potential treatment for paediatric patients with acute cannabis-induced 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.”
The double-blind, randomised, placebo-controlled Phase I study will examine the tolerability, safety and pharmacokinetics of IV selonabant in healthy adult participants aged between 18 and 25 years.
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By GlobalDataIt received NIDA and National Institutes of Health support under award number U01DA059995.
Cunningham added: “In addition to the continuing support from NIDA, our interactions with the [US] Food and Drug Administration have confirmed our belief that there is a significant and growing unmet need for a treatment for children exposed to cannabis toxicity.”
The company previously assessed selonabant as an oral therapy in a Phase II study, demonstrating its capability to obstruct and reverse the negative effects of ACI in healthy adult subjects challenged with oral THC.
Anebulo has prioritised the development of this formulation as a potential therapy for paediatric subjects experiencing acute cannabis-induced toxicity.
