Anebulo Pharmaceuticals announces feedback from FDA on ANEB-001 path

Anebulo Pharmaceuticals announced feedback from the FDA following a Type B meeting in July. The FDA indicated that a single well-controlled study of ANEB-001 in ACI patients presenting to the emergency department combined with a larger THC challenge study in volunteers could potentially provide substantial evidence to support a new drug application. In addition to receiving the final minutes of the FDA meeting, Anebulo has also completed dosing in an open-label Part C extension of its Phase 2 clinical trial to evaluate the safety and efficacy of ANEB-001 at higher challenge doses of THC. Twenty healthy adult volunteers participated in Part C of the study. Cohort 7 received a single oral dose of 40 mg of THC together with a single oral dose of 10 mg of ANEB-001. Cohort 8 received a single oral dose of 60 mg of THC together with a single oral dose of 20 mg of ANEB-001. In the earlier Part B of the study, a single oral dose of 40 mg THC without ANEB-001 was not well tolerated due to overt THC-related effects. However, the use of even higher THC challenge doses was considered acceptable by the IRB provided that all subjects would also receive ANEB-001. Part C of the study was therefore conducted as open-label without a placebo arm. Subjective and objective assessments performed during the open-label Part C of the study were similar to those used in Parts A and B, with the addition of several new outcome measures intended to explore further evidence of clinically meaningful effects. Based on preliminary safety observations, THC challenge doses of 40 mg and 60 mg were well-tolerated when dosed in combination with ANEB-001, and all treatment-related adverse events were mild and transient. Full safety, pharmacokinetic, or PK, and pharmacodynamic data from the study, as well as results at higher doses of THC, are expected in 4Q 2023.