Aelis Farma Announces Positive Results of Non-Clinical Studies Required by Regulatory Agencies to Enter Its First Cb1-SSI, AEF0117, in Phase 3 Clinical Trial for the Treatment of Cannabis Use Disorder

Aelis Farma announced that it has successfully completed all the regulatory non-clinical studies necessary to enter in phase 3 clinical trials AEF0117, the Company's most advanced signaling specific inhibitor of the CB1 receptor of the endocannabinoid system. AEF0117 is currently tested in a large phase 2b study in people with cannabis use disorder (CUD). CUD is the current definition of cannabis abuse and dependence in the DSM5, the reference diagnostic manual for psychiatric diseases.

Recruitment is on track and results are expected in second quarter 2024. Thanks to the successful completion of the non-clinical development ahead of schedule, AEF0117 will be prepared to enter pivotal phase 3 clinical trials for CUD upon successful completion of the present phase 2b clinical study and regulatory clearance of the phase 3 protocol. Both compounds have a favorable safety profile and no effect on normal behavior perse.

Aelis Farma, using its proprietary screening platform, has also identified new families of CB1 compounds, chemically and functionally differentiated from the first two, but sharing the core mechanism of action. The development of AEF0117, for the treatment of cannabis use disorder is progressing according to plan. AEF0117 is current in a phase 2b study conducted in 11 clinical centers in the US and coordinated by Pr.

Frances Levin (Columbia University, New York). The study, that aims to enroll up to 330 patients, progresses according to plan with recruitment expected to be finalized by fourth quarter 2023. The first results should be available in second quarter 2024.

To ensure a smooth transition of AEF0117 to the phase 3 study after a positive phase 2b, Aelis Farma initiated, in parallel with the phase 2b clinical studies, a series of toxicology studies required by the regulatory authorities. These confirmed the very favorable therapeutic index >13,000 time the active dose. CB1-SSi have consequently the potential to provide new treatments for several brain diseases.

Aelis Farma is currently developing two first-in-class clinical-stage drug candidates: AEF0117 is currently in a phase 2b study completed in 11 clinical centers in the U.S and coordinated by Pr.Frances Levin (Columbia University, New York).