Positive results shown in ongoing phase 2 trial of cannabinoid intoxication treatment
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A biopharmaceutical company has announced positive interim data from the first two cohorts in an ongoing phase 2 clinical trial of its treatment for acute cannabinoid intoxication.
According to a release from Anebulo Pharmaceuticals, ANEB-001 is an orally bioavailable, rapidly absorbed, small molecule cannabinoid receptor antagonist that aims to address the unmet medical need for a specific antidote for acute cannabinoid intoxication (ACI).
In the current study, conducted in healthy adult occasional cannabis users at the Centre for Human Drug Research in the Netherlands, each cohort was challenged with 21 mg of oral THC, and at twice the THC dose from Part A. Participants then received either 30 mg (cohort 1) or 10 mg (cohort 2) oral doses of ANEB-001, or matching placebo.
Based on these data, participants given a higher 21 mg oral THC dose and treated with placebo showed greater central nervous system effects than observed in Part A with 10.5 mg THC. The effects included a substantial increase in feeling high and body sway, decreased alertness and slightly increased heart rate compared with baseline, Anebulo reported in the release.
In contrast, participants given 10 mg or 30 mg of ANEB-001 led to significant and sustained reductions in the visual analog scale, feeling high score, improvement in the VAS alertness scale, and a reduction in THC-induced body sway, compared with placebo.
Per the release, 100% of participants given 21 mg THC with placebo in both cohorts met the VAS threshold for feeling high (>20 mm on the 100 mm VAS scale) compared to only 1 subject per group treated with ANEB-001 at 10 mg or 30 mg doses.
“Using lower doses of ANEB-001 to reduce ACI symptoms should allow us to optimize tolerability, while providing an even more favorable cost of goods if ANEB-001 is approved,” Anebulo CEO Simon Allen stated in the release. “We believe ANEB-001 will play a critical role in reducing the burden of ACI for the patient and the healthcare system.”
Results of Part A of the study, announced in July, showed positive effects of 50 mg or 100 mg of ANEB-001 in reducing the effects of a 10.5 mg oral THC dose. Anebulo said in the release it plans to enroll at least six cohorts in Part B, with up to 15 subjects per cohort, randomized in a 2:1 ratio of active compared with placebo.