[Lifeking/Adobe Stock]
The FDA indicated that a study of the cannabinoid antagonist ANEB-001 in ACI patients presenting to emergency departments together with a larger THC challenge study could support a new drug application.
ANEB-001 is Anebulo’s lead product candidate.
The company recently wrapped up an open-label part C extension of its phase 2 clinical trial to investigate ANEB-001’s efficacy at high challenge doses of THC. This study involved 20 healthy volunteers, broken into two cohorts:
- Cohort 7: Received 40 mg of THC with 10 mg of ANEB-001.
- Cohort 8: Administered 60 mg of THC and 20 mg of ANEB-001.
Early observations indicate that these THC challenge doses with ANEB-001 were well-tolerated. The company anticipates comprehensive results from this study later in the year. The company also has an observational study of patients with ACI who report to emergency departments.
Anebulo notes that historical data from earlier phases of the study indicate that ANEB-001 was well-tolerated with no severe adverse events. The administration of ANEB-001 post a THC challenge appeared to alleviate symptoms of THC intoxication, which can include euphoria, nausea and dizziness.
THC overdose a growing problem
As more states have legalized or decriminalized marijuana, the U.S. has witnessed a steep jump in cannabinoid-related emergency department visits. In 2019, the figure of such visits hit 1.7 million, representing a 15% spike from the prior year. Despite the worrisome trend, there are no FDA-approved treatments for acute cannabinoid intoxication (ACI). At present, individuals dealing with adverse effects of cannabis overdose have few options but to wait for the symptoms to subside.
Proportional rise in cannabis-involved ER visits by age group from 2019 to 2022
The data on cannabinoid-related emergency department visits is alarming, with a 15% increase observed from 2018 to 2019, according to CDC. The COVID-19 pandemic has worsened the situation, fueling cannabis use in minors. But according to CDC data, cannabis-involved emergency department (ED) visits were up for youths aged 0–14 years even before 2019 as cannabis legalization expanded across the U.S. In fact, the biggest increase in cannabis-related emergency department visits involved children aged 10 years and younger and those aged 11–14 years.
A timeline of ANEB-001 development, a cannabinoid antagonist
Anebulo Pharmaceuticals launched a phase 2 proof-of-concept trial for ANEB-001 in the Netherlands in December 2021. The company made several advances in the following year, revealing positive topline data from phase 2 part A on July 5. After that, it announced positive part B data on September 26. Before the end of 2022, the company had wrapped up dosing of all subjects, and unveiled preliminary data from phase 2 part on January 9, 2023. A pivotal Type B meeting with the FDA took place in July 2023.
Filed Under: clinical trials, Drug Discovery, Psychiatric/psychotropic drugs, Regulatory affairs
