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Anebulo Therapeutics is preparing for further discussions with the US Food and Drug Administration (FDA) to finalise upcoming clinical trial designs of ANEB-001 in acute cannabinoid intoxication (ACI), CEO Simon Allen told Clinical Trials Arena.

Anebulo will conduct one trial in an emergency department (ED) setting and a larger challenge study with volunteers. This was indicated by the FDA as potentially substantial to support a new drug application (NDA), according to a press release in August.

ANEB-001 is a cannabinoid receptor antagonist in development for ACI and substance abuse.

While the two separate trials are anticipated to run in parallel, they may not be initiated concurrently. Also, the trials are designed to overlap with rational endpoints in order to combine the safety data. Anebulo plans to dose the first patient in the first half of 2024.

Although the company successfully ran its Phase II trial in the Netherlands, cannabis regulation and decriminalisation in Europe is a few years behind the US, Allen explained. Anebulo is seeking more acute opportunities to reach the market, therefore the upcoming Phase III trial will open sites in the US.

Trial design and patient population

The exact trial design and estimated number of patients is yet to be discussed with the FDA. Allen shared that the FDA expects to see a placebo-controlled trial. In the Phase II trial, the Part C extension was open-label due to concerns over high THC levels administered to the volunteers.

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Allen said: “Given this nuance, ongoing discussions with the FDA is what we’re focused on in order to come up with an agreeable suitable protocol for both trials.”

Anebulo also anticipates including participants with polysubstance abuse, meaning one or more substances are taken together or within a short period of time. While it would be ethically and legally challenging to study such patient population in a volunteer setting, the company plans to involve these patients in the ED trial.

In both challenge and ED trials, Anebulo anticipates recruiting younger participants, as young as 16 years old, to provide additional benefit, Allen noted.

Phase II data

Alongside the feedback from the FDA, Anebulo announced the completion of the Phase II Part C extension. In Part C, Anebulo investigated 40mg and 60mg doses of THC administered with a single 10mg and 20mg dose of ANEB-001, respectively.

Preliminary safety observations showed that 40mg and 60mg doses of THC were well-tolerated when dosed in combination with ANEB-001. Anebulo expects to report full safety, pharmacokinetic (PK), and pharmacodynamic data in Q4 2023. Anebulo first reported positive results from the Part A of the trial in July 2022.

Clinical Trials Arena has previously investigated why the pharma industry is neglecting the unmet needs of substance use disorders.