Aelis Farma announces results of its Phase 2B clinical trial of AEF0117 in participants with cannabis use disorder (CUD) Page 1

Regulatory news:

Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a clinical-stage biopharmaceutical company specializing in the development of treatments for brain diseases, today announces results from the Phase 2B clinical trial of AEF0117 conducted by Aelis Farma¹evaluating efficacy and safety in treatment-seeking participants with moderate to severe cannabis use disorder (CUD) who used cannabis at least 5 days/week at baseline. In this study population, 82% of participants had severe CUD.

The purpose of this landmark Phase 2B study was to demonstrate that AEF0117 reduces cannabis use and to determine the endpoints and optimal dosing of AEF0117 for future studies. Three doses of AEF0117 (0.1, 0.3, 1 mg once daily for 12 weeks) were evaluated and multiple endpoints (primary, secondary and exploratory) measuring changes in cannabis use and their consequences for participants were analyzed.