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

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.

Pier Vincenzo Piazza, CEO of Aelis Farma, concludes: "Completion of the last patient, last visit in the phase 2b study with AEF0117, the largest study ever performed for a treatment of cannabis addiction, marks a significant milestone in our clinical journey and demonstrates our ability to respect timelines announced to the market. I would like to send heartfelt thanks to all the persons who have contributed to this significant advancement in AEF0117's development, the investigators, the patients and the extremely dedicated Aelis team. We remain committed to our roadmap for AEF0117 to offer an effective treatment of cannabis addiction, an increasingly prevalent and worrying condition worldwide."

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.

Patients received 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 can reduce cannabis use by increasing the proportion of subjects consuming cannabis ≤1 day per week compared to the placebo. Secondary endpoints include the proportion of patients achieving other levels of reduced cannabis use including abstinence, and potential improvement in their quality of life. These secondary endpoints, if positive, could potentially serve as alternative primary objectives for the future phase 3 trials.