Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biotechnology company focused on treatments for cannabinoid-related conditions, announced today that the first participants have been dosed in its Phase 1 single ascending dose (SAD) clinical trial evaluating an intravenous (IV) formulation of selonabant.
Study Design and Purpose
The randomized, double-blind, placebo-controlled trial will assess the safety, tolerability, and pharmacokinetics of IV selonabant in healthy volunteers aged 18 to 25. By gradually increasing dose levels, the study aims to understand how the drug is processed in the body and to determine a safe therapeutic range.
Building on Previous Research
Anebulo previously tested an oral version of selonabant in a Phase 2 study, where the drug showed potential in reducing or reversing the adverse effects of acute cannabis intoxication following a controlled THC challenge. Transitioning to an IV formulation marks a strategic step forward, particularly as the company positions selonabant for pediatric use in emergency settings, where rapid action is crucial.
Addressing Pediatric Risks
The need for an antidote is especially pressing among children, who face heightened risks from cannabis exposure. Clinical observations indicate that pediatric patients are more vulnerable to central nervous system depression, respiratory complications, and, in severe cases, coma or death. Differences in age-related receptor distribution may make children particularly sensitive to cannabinoids, reinforcing the case for a targeted therapeutic.
Conversations with the U.S. Food and Drug Administration have further highlighted the lack of available treatments for pediatric cannabis toxicity, underscoring the potential role of selonabant IV as a first-in-class intervention.
Funding and Support
The Phase 1 program is supported in part by a collaborative grant from the National Institute on Drug Abuse (NIDA), including nearly $1 million in recently secured funding for the second year of the project.
Outlook
If proven safe and effective, selonabant IV could emerge as a rapid-response therapy for cannabis overdoses in both adult and pediatric populations. Anebulo emphasized, however, that results remain subject to clinical outcomes, regulatory review, and broader adoption across the healthcare system.
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