Anebulo Pharmaceuticals ANEB announced positive topline data from Part A of an ongoing Phase 2 clinical trial of its drug candidate ANEB-001 for patients with acute cannabinoid intoxication (ACI).
The Part A portion of Phase 2 study evaluated effectiveness of a single dose of ANEB-001 in treating healthy subjects challenged with delta-9-tetrahydrocannabinol.
Simon Allen, Chief Executive Officer, commented : "We believe this proof-of-concept trial demonstrates ANEB-001's potential to reverse the symptoms of ACI for many of the five thousand cannabinoid intoxicated individuals visiting our emergency departments in the United States on a daily basis.”
The study was conducted at the Centre for Human Drug Research (CHDR) in the Netherlands and enrolled 60 healthy adult occasional cannabis users to three treatment arms of 20 subjects per arm.
With the positive data readout from Part A study, Anebulo plans to initiate Part B of the study by the end of third quarter 2022 to evaluate lower doses of ANEB-001.
The company is planning to submit an Investigational New Drug application (IND) for ANEB-001 to initiate clinical trials in the United States by the end of 2022.
Anebulo shares are trading higher 21 percent at $6.50 during Tuesday’s pre-market session.
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