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

Regulatory News:

Aelis Farma (ISIN: FR0014007ZB4 – Ticker: AELIS), a clinical-stage biopharmaceutical company specializing in the development of treatments for brain disorders, today announces 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 Q2 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.

Pier Vincenzo Piazza, CEO of Aelis Farma, said: “We are very pleased with the successful end of this campaign of non-clinical studies which shows three important things. First, AEF0117 confirms its safety profile with a safe dose 13,000 times higher than the active dose, which means that no side effects of AEF0117 have been identified in animals. Second, AEF0117 will be ready to enter phase 3 clinical studies after the completion of the current phase 2b in cannabis use disorder, optimizing the pathway to market. Third, Aelis Farma delivers on its promises, in this case ahead of time, highlighting our ability to perform complex clinical and non-clinical programs in parallel. I would like to take this occasion to thank the Aelis team for this great achievement”.

The favorable safety profile of CB₁-SSi resolves a bottleneck in CB₁ pharmacology and opens the way to several markets with strong medical needs

CB₁-inhibitors, a main objective for drug development upended by safety concerns

Developing CB₁ antagonists has been a major goal for the pharmaceutical industry with most of the main players engaged in this endeavor. Indeed, due to its important and diverse physiological roles, CB₁ receptors could be a gateway to addressing several peripheral and central nervous system diseases with significant medical needs. For example, for the periphery: metabolic, fibrotic and skin diseases and for the brain: addiction, cognitive impairments, psychosis and autism spectrum disorders. Unfortunately, the first generation of CB₁ antagonists had unacceptable behavioral side effects and poor therapeutic index often inferior to 10 which led either to their withdrawal from the market (Sanofi, rimonabant) or to the suspension of their developments (e.g. Pfizer, Merck).