Aelis Farma Announces Completion of Patient Randomization for Phase 2b Study with AEF0117 for the Treatment of Cannabis Addiction

Regulatory News:

Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a clinical-stage biopharmaceutical company specializing in the development of treatments for brain disorders, today announces to have reached a key milestone by successfully completing the recruitment of 333 patients suffering from cannabis addiction in its Phase 2b clinical study with AEF0117.

AEF0117 is the first of a new class of proprietary drugs developed by Aelis Farma, the Signaling Specific inhibitors of the CB₁ receptor of the endocannabinoid system (CB₁-SSi). The ongoing multicenter Phase 2b study aims to demonstrate the effectiveness of this "first-in-class" compound in treating cannabis addiction, currently defined as CUD (Cannabis Use Disorder) in the DSM-5, the reference diagnostic manual of mental disorders.

The recruitment and randomization of the 333 study patients were accomplished across 11 clinical centers in the United States, under the coordination of Pr. Frances Levin from Columbia University (New York). The double-blind, placebo-controlled trial involves the administration of either placebo or one of the three tested doses of AEF0117 (0.1 mg, 0.3 mg, and 1 mg) once daily for 3 months. The primary objective of the study is to assess whether AEF0117 reduces cannabis consumption by demonstrating an increase in the proportion of subjects consuming cannabis ≤1 day per week compared to the placebo. The proportion of patients achieving other levels of reduced consumption, along with the potential improvement in their quality of life, will also be examined as secondary endpoint. Initial results are expected in line with the timeline previously announced for the second quarter of 2024.

Pr. Frances Levin, the study's principal investigator and Professor of Psychiatry at Columbia University, commented: “The successful recruitment of 333 patients, according to the predetermined schedule, demonstrates the real demand for treatment experienced by individuals suffering from CUD. We would like to thank the participants as well as the medical teams of the eleven centres of this study, for their trust, effort, and dedication to this important clinical trial. We eagerly await results that could be a critically important and novel therapeutic intervention for the treatment of moderate to severe cannabis use disorder.”