Dr. Pier Vincenzo Piazza, co-founder and CEO of Aelis Farma
Since our listing on Euronext Paris in February 2022, the Aelis Farma team has continued to deploy all its effectiveness and skills to reach its strategic objectives announced at the time of the IPO. I am very proud to inform you that all these objectives have been achieved as planned:
For AEF0117 targeting the treatment of cannabis addiction: A phase 2b study began in June 2022. This clinical trial will include approximately 330 patients in 9 clinical centers in the USA and is coordinated by Columbia University (NY). Recruitment is progressing as planned and the trial should deliver its first results in 2024.
For AEF0217 targeting the treatment of cognitive disorders, including those linked to Down syndrome (Trisomy 21): In November 2022, the results of the AEF0217 phase 1 clinical program in healthy volunteers were announced. They were quite positive and showed that AEF0217 has a very favorable safety and pharmacokinetic profile, with no serious or severe adverse effects identified. In December 2022, a phase 1/2 clinical trial of AEF0217 in people with Trisomy 21 was started. This monocentric double-blind clinical trial conducted with the Hospital del Mar Medical Research Institute in Barcelona, will include around 45 participants with Trisomy 21. It aims to analyze both the safety and pharmacokinetic of AEF0217 and could also provide information about the therapeutic activity of this compound for the treatment of the cognitive impairments of Trisomy 21. The trial is expected to end in the second half of 2023.
Finally, concerning our research platform: Some new, original and innovative molecules are likely to enter the pre-clinical proof of concept phase in 2023. Our research platform has met our expectations by validating new molecular entities that can modify in new ways only part of the activity of the CB1 receptor, which gives them a particularly selective and favorable pharmacological profile. These new drug candidates could enable us to offer new treatments for other brain disorders involving the CB1 receptor.
2023 is expected to be as dynamic and promising as 2022 and we will deploy all our know-how and determination to meet again our objectives in a timely manner.