Aelis Farma Announces the Last Patient, Last Visit in its Clinical Phase 2b Trial with AEF0117 for the Treatment of Cannabis Use Disorder

Regulatory News:

Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a clinical-stage biopharmaceutical company specializing in the development of treatments for brain diseases, is pleased to announce today a significant milestone in the clinical development of AEF0117: the last patient visit in the clinical phase 2b study, which included 333 individuals seeking treatment for cannabis use disorder (CUD), has been completed.

AEF0117 represents a novel class of drugs developed by Aelis Farma, the Signaling-Specific inhibitor of the CB₁ receptor ("CB₁-SSi"). This phase 2b multicenter study aims to demonstrate the efficacy and safety of this "first-in-class" compound in treating cannabis addiction, currently defined as CUD in the DSM-5, the reference diagnostic manual of mental disorders.

This significant advancement marks the conclusion of clinical data collection and the start of in-depth analysis. The company confirms its intention to announce the study results in the third quarter of this year.

Pr. Frances Levin, the study's principal investigator and Professor of Psychiatry at Columbia University, comments: "Completion of the last patient, last visit is a crucial step towards unveiling the potential efficacy of AEF0117 as a treatment of cannabis addiction. This milestone marks the end of data collection and the beginning of in-depth analysis. We eagerly await results that could offer a crucial and innovative therapeutic alternative for the treatment of cannabis use disorder. We also wish to thank all the medical teams involved in the study for their efforts and dedication and send a special thanks to the CUD participants for their trust and participation to the study.”

AEF0117 has a favorable therapeutic index >13,000 times the active dose confirmed in long-term chronic oral toxicity studies (6 months in rats and 9 months in dogs) which support the potential chronic use of AEF0117 in humans without time restriction. In addition, the lack of adverse effect in juvenile toxicity studies would support administration of AEF0117 in adolescents, an important target population in CUD. Finally, the reproductive toxicology studies show that AEF0117 does not modify embryonic and embryofetal development.