Anebulo Pharmaceuticals ( NASDAQ: ANEB ) said a phase 2 trial of oral drug ANEB-001 met the main goal of reducing cannabinoid intoxication.
The company reported data from part A of an ongoing phase 2 trial, conducted in the Netherlands, of ANEB-001 against placebo to treat acute cannabinoid intoxication (ACI), according to a July 5 press release.
Part A included 60 people challenged with delta-9-tetrahydrocannabinol (THC), the primary psychoactive component of cannabis.
The company said data showed that 10% of people in the 50-mg ANEB-001 group and 30% in the 100-mg group reported feeling high compared to 75% of those on placebo.
Anebulo added that statistically significant and sustained reductions in key THC-related central nervous system (CNS) symptoms.
The company noted that ANEB-001 was well tolerated.
"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," said Anebulo CEO Simon Allen.
Anebulo ( ANEB ) said it plans to start part B of the study by the end of Q3 to evaluate lower doses of ANEB-001.
The company also intends to file by the end of 2022 an application seeking U.S. FDA approval to begin trials of ANEB-001 in the U.S.
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Anebulo's drug ANEB-001 helps reduce cannabis high in phase 2 study