Biopharmaceutical company Anebulo Pharmaceuticals Inc (Nasdaq: ANEB) on Monday provided an important update on its lead product candidate, selonabant (ANEB-001), for the treatment of acute cannabis-induced toxicity in children.

Following the positive results from a Phase 2 study involving adult subjects, where oral selonabant effectively blocked or reversed key central nervous system (CNS) effects of THC, Anebulo met with the U.S. Food and Drug Administration (FDA) to discuss advancing an intravenous (IV) formulation of selonabant. This is aimed at providing a much-needed, targeted therapy for treating cannabis toxicity in paediatric patients.

The FDA acknowledged the unmet need for a paediatric treatment and proposed a close collaboration to expedite the development of the IV formulation. Anebulo plans to initiate its Phase I study of IV selonabant in healthy adults in the first half of 2025.

Additionally, Anebulo announced the closing of a private placement offering, raising USD15m by issuing 15.2 million shares at USD0.99 per share. The funds will be used to support the ongoing development of selonabant. The company also amended its Loan and Security Agreement (LSA) to reduce the maximum loan size to approximately USD3m, easing its financial obligations.

Selonabant is a small molecule antagonist of the cannabinoid receptor type-1 (CB1) under development as a specific antidote for acute cannabis-induced toxicity, including both acute cannabinoid intoxication (ACI) in adults and unintentional cannabis poisoning in children. The drug has demonstrated promising results in clinical trials, with plans for both oral and IV formulations. The company is currently scaling up the IV formulation for future clinical trials targeting paediatric patients.