Anebulo's ANEB-001 Reduces Cannabis Intoxication In Healthy Participants

  • 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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