- Anebulo Pharmaceuticals Inc ANEB has announced topline data from Part A of an ongoing Phase 2 trial of ANEB-001 to treat acute cannabinoid intoxication (ACI).
- Part A was a 60-subject trial designed to evaluate the effectiveness of a single dose of ANEB-001 in healthy subjects challenged with delta-9-tetrahydrocannabinol (THC), the primary psychoactive constituent of cannabis.
- The data demonstrated a statistically significant reduction in key symptoms of ACI, with only 10% of subjects in the 50 mg ANEB-001 group and 30% in the 100 mg group reporting feeling high compared to 75% of subjects in the placebo group.
- ANEB-001 was well tolerated in these healthy volunteers.
- Preliminary safety data showed all adverse events were mild and transient, except for one subject in the 50 mg ANEB-001 group who experienced moderate nausea and vomiting.
- Subjects challenged with THC and treated with placebo showed substantial CNS effects, including feeling high, decreased alertness, increased body sway, and increased heart rate.
- The company plans to initiate Part B of the study by the end of Q3 2022 to evaluate lower doses of ANEB-001.
- Preparations are ongoing for an observational study on ACI subjects in the emergency department. Submission of an Investigational New Drug application for ANEB-001 to initiate U.S. trials is anticipated by the end of 2022.
- Price Action: ANEB shares are up 17.21% at $6.30 premarket on the last check Tuesday.
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