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

Regulatory News:

Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a clinical-stage biopharmaceutical company focused on developing treatments for brain diseases, today announces results from the Phase 2B clinical study conducted by Aelis Farma with AEF0117¹evaluating its efficacy and safety in treatment-seeking participants with moderate to severe Cannabis Use Disorder (CUD) who used cannabis ≥5 days/week at baseline. In this study population, 82% of participants had severe CUD.

The aim 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 use in 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 impact on participants were analyzed.