Dr. Pier Vincenzo Piazza,
Co-founder and CEO of Aelis Farma
The founding values of Aelis Farma are a strong commitment to innovative and rigorous research and development tailored to maximize the success of our clinical programs. Our goal is to introduce pioneering therapeutic tools in areas where medical needs remain unmet, in particular in the field of brain diseases. These values and commitments, shared by whole team have been the key of our success.
The year 2023 has been marked by significant advances in the development for our two drug candidates, AEF0117 for cannabis related disorders and AEF0217 for the treatment of cognitive deficits, the first of Aelis Farma's new generation of drugs, the CB1-SSi.
AEF0117’s development, from chemistry to phase 2a efficacy results in cannabis addict, was published in June 2023 in Nature Medicine. This prestigious publication demonstrates the recognition by the scientific community of the potential of AEF0117 and more generally of the new CB1-SSi pharmacological class, first described in this article.
AEF0117 has also significantly progressed in the phase 2b evaluating its efficacy for the treatment of cannabis addiction. Halfway through this study, in June 2023, we received a positive recommendation to continue without modification from the Data Safety Monitoring board (DSMB), which confirmed the safety of AEF0117. In December 2023, we have also completed the recruitment of the 333 patients of this study. Finally, the positive results obtained from non-clinical toxicity and pharmacological studies will enable the advancement to phase 3 of AEF0117 upon the success of phase 2b study.
For AEF0217, substantial efforts have been made to ensure the progression of the phase 1/2 study in individuals with Down syndrome (trisomy 21). This study, primarily aims at assessing the safety of AEF0217 in this fragile population and if successful, will allow the initiation of a multicenter phase 2b study investigating the efficacy of AEF0217 for the treatment of cognitive deficits in Down syndrome that should start by late 2024/early 2025.
Finally, our proprietary platform has identified several CB1-SSi with new properties that should allow us to target a broader range of diseases involving the CB1 receptor.
Beyond these significant developments, we have also strengthened our leadership teams with the appointment of Arsène Guekam as Chief Corporate Development Officer. His deep knowledge of financial markets and healthcare sectoral trends will be a great asset to Aelis Farma.
In 2024, our main ambition is to deliver on the clinical study schedule: obtain the first results of the phase 2b with AEF0117 after the summer break 2024 and complete the phase 1/2 study with AEF0217. Furthermore, we also maintain the ambition to initiate the development of a third CB1-SSi by the end of 2024.
Thanks to the expertise and commitment of our team and the support of our shareholders, we are confident to achieve these goals and progress towards becoming a leading player in the field of brain disease.