Anebulo Pharmaceuticals has reported positive topline findings from part A of Phase II clinical trial for analysing the potential of ANEB-001 to treat acute cannabinoid intoxication (ACI).
Carried out at the Centre for Human Drug Research (CHDR) in the Netherlands, the randomised, double-blind, placebo-controlled Part A of the trial enrolled 60 healthy adult subjects who use cannabis occasionally.
All participants were challenged with a single oral 10.5mg delta-9-tetrahydrocannabinol (THC) dose and subsequently received single doses of either 50mg or 100mg ANEB-001 or placebo.
They were observed for 24 hours to evaluate the safety, tolerability and pharmacokinetics of ANEB-001 and frequently tested to check the potential effects on endpoints linked to ACI symptoms.
The tests comprised various established measures of subjective CNS symptoms utilising visual analog scale (VAS) evaluations, and objective measures of intoxication.
According to the positive findings, a highly statistically significant decline in key ACI symptoms was observed.
Only 10% of participants who received 50mg ANEB-001 arm and 30% in the 100mg arm reported feeling high versus 75% in the placebo arm.
In addition, ANEB-001 was found to be well tolerated in these subjects.
As per the initial safety data, all adverse events in the trial were seen to be mild and transient, except a volunteer in the 50mg ANEB-001 arm experiencing moderate nausea and vomiting.
ANEB-001 offered a strong and lasting decline in the VAS feeling high score and improvement in the VAS alertness scale versus placebo.
In the trial, 50mg and 100mg doses of ANEB-001 showed similar effects, indicating that lower doses can be explored.
Based on the latest Part A data, the company intends to commence the Part B of the trial analysing lower doses of ANEB-001 at CHDR by the end of the third quarter of this year.
Anebulo CEO Simon Allen said: “With no FDA approved therapy, individuals intoxicated with cannabinoids have few treatment options and may require expensive follow-on interventions for neuropsychiatric complications such as anxiety and acute psychosis.
“ANEB-001 has the potential to mitigate these unfortunate circumstances and reduce their burden on individuals, society, and our healthcare system.”