Aelis Farma SA announced 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.

Finally, the productive toxicology studies show that AEF0117 does not modify embryonic and embryofetal development. The successful early completion of the toxicity studies described above and of additional non-clinical development studies, positions AEF0117 to enter phase 3 clinical trials for the treatment of CUD upon positive results of the present phase 2b clinical trial and regulatory agreement of the phase 3 protocol. To reach this goal, the company plans to request an end-of-phase 2 (EOP2) meeting with the FDA in the fourth quarter of this year.

Phase 2b clinical study with AEF0117 for the treatment of cannabis addiction. Under the coordination of Professor Frances Levin at Columbia University (New York) and of Aelis Farma clinical team, recruitment and randomization of the 333 patients for the phase 2b trial of AEF0117 at 11 clinical centers in the United States were completed in December 2023. The last visit for the last patient was completed mid-April 2024.

These secondary endpoints, if positive, could potentially serve as alternative primary objectives for the future phase 3 trials. The Phase 2b study is part of the clinical program for AEF0117, which received $7.8 million of total funding from the National Institutes of Health (NIH), with $4.5 million allocated in late 2021 for the current development phase, aiming to ready the compound to enter phase 3. The remaining $3.3 million were previously dedicated to help financing phase 1 and a Phase 2a study with AEF0117. Within three months following the end of phase 2 meeting with the FDA, Indivior will be able to exercise its license option, trigger the payment of a $100 million license fee, up to an additional $340 million in milestone payments involving upon the achievement of development, regulatory, and commercial milestones, as well as royalties on net sales of AEF0117 ranging from 12% to 20%.

Aelis Farma is currently developing two first-in-class drugs developed by AelisFarma, the Signaling- Specific inhibitor of the CB1 receptor (CB1-SSi). This Phase 2b multicenter study aims for the treatment of cannabis addiction, which is expected to be in the second quarter of this year.