Anebulo Pharmaceuticals, Inc., announced complete results from its randomized, double-blind, placebo-controlled phase 2 clinical trial, evaluating ANEB 001 as a potential treatment for acute cannabinoid intoxication ACI in healthy volunteers challenged with oral THC. Part B of the study was an adaptive design that included six cohorts of up to 15 healthy adults to examine different doses of THC and ANEB 001, and the impact of delayed dosing of ANEB 001 or placebo. 134 healthy subjects were enrolled in the Phase 2 study, as part of Parts A and B.
Simon Allen, CEO of Anebulo, stated that the positive results of the Phase 2 proof of concept study are very encouraging and will have significant clinical implications for the unmet needs of patients presenting to emergency departments with ACI. We believe that the complete data from this study, along with data from our observational study in ACI subjects and our PK PD modeling efforts, will provide support for the design of a registrational trial. We are in the process of requesting an end of phase 2A meeting with the FDA to discuss the final data from this study. We expect the meeting to be within 75 days of the request, but we acknowledge that it could be longer. Based on the final data for part B of the study, a single low oral dose of ANEB 001 10 mg administered 1 hour after a THC challenge dramatically reversed key psychotropic effects of THC doses as high as 30 mg, including a reduction in the visual analog scale VAS for feeling high and an improvement in VAS alertness and reduced body sway. A single 10 mg of ANEB 001 administered one hour after THC achieved statistical significance on all primary outcomes, including a reduction in VAS feeling high, improved body sway and a reduction in heart rate, in a pre-specified pooled analysis of data for the combined 21 mg or 30 mg THC dose levels. ANEB 001 also reduced the time required for the THC effects to normalize back to baseline.
This is the place where money is raised, M&A starts, and companies meet key partners. On April 11 -- 12 at Fontainebleau Miami Beach Hotel in Florida.