Anebulo Pharmaceuticals, Inc. announced that the first patient has been dosed in a Phase 2 proof-of-concept clinical study investigating ANEB-001 as a potential treatment for acute cannabinoid intoxication. In addition, Anebulo recently held a pre-IND meeting with the U.S. Food and Drug Administration during which the company received valuable guidance regarding the clinical development of ANEB-001 in the U.S. Importantly, the FDA noted that a challenge model whereby subjects are exposed to THC in a controlled clinical setting may be acceptable to investigate primary efficacy, which would allow for the more efficient development of ANEB-001. Further, the FDA suggested that Anebulo submit a model-informed drug development paired-meeting request.

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study at a single site in the Netherlands to evaluate ANEB-001 in the inhibition of THC-induced effects. The new trial design anticipates enrolling a total of 60 patients in Part A, randomized 1:1:1 between 50mg of ANEB-001, 100mg of ANEB-001 and placebo. All participants will receive 10.5mg of THC as a challenge drug.

The goal of Part A is to deliver clinical proof-of-concept that ANEB-001 can reverse the effects of THC. Part B will enroll additional cohorts and further explore the relationship between THC and ANEB-001 dose levels and clinical efficacy, and provide additional datapoints for pharmacokinetic/pharmacodynamic models. Anebulo believes the ability to quickly adapt the protocol and test additional hypotheses will save time and reduce development risk while designing future trials in 2022.