Anebulo Pharmaceuticals, a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication (ACI) and substance addiction, today announced positive interim data from the first two cohorts of Part B of its ongoing Phase 2 clinical trial evaluating ANEB-001 as a treatment for ACI.
“These new Part B data showed that 10mg of ANEB-001 reversed key symptoms of ACI, comparing favorably to our Part A data showing similar effects with 50mg and 100mg. The 10mg data is even more impressive considering we doubled the THC challenge to 21mg in that cohort,” said Simon Allen, Chief Executive Officer of Anebulo. “Using lower doses of ANEB-001 to reduce ACI symptoms should allow us to optimize tolerability, while providing an even more favorable cost of goods if ANEB-001 is approved. We are currently exploring the effects of delayed dosing to better understand real-world conditions. In this circumstance, we challenge subjects with THC one hour before administering ANEB-001. With no FDA approved therapeutic, ACI often requires lengthy emergency department stays with expensive follow-on interventions for neuropsychiatric complications such as anxiety and acute psychosis. We believe ANEB-001 will play a critical role in reducing the burden of ACI for the patient and the healthcare system.”
ANEB-001 is a small molecule cannabinoid receptor antagonist, to address the medical need for a specific antidote for ACI. ANEB-001 is an orally bioavailable, rapidly absorbed treatment candidate that the company anticipates will reverse the symptoms of ACI, in most cases within 1 hour of administration. ANEB-001 is protected by one issued patent and rights to one patent application covering various methods of use of the compound and delivery systems.