Dr. Pier Vincenzo Piazza, Co-founder and CEO of Aelis Farma
The first half of 2025 was characterized by important achievements in the development of our drug candidates. The final analysis of the Phase 2b study with AEF0117 confirmed its ability to significantly reduce cannabis consumption in certain patients, although the primary endpoint was not met.
With an in-depth understanding of AEF0117’s effects, we remain fully committed to identifying the best partnership or regulatory pathways to advance its development.
For AEF0217, following the successful Phase 1/2 study in individuals with Down syndrome, we are preparing an international multicentre Phase 2b study aimed at confirming AEF0217’s potential to improve behavioural deficits in this population. This study is expected to begin in the second half of 2025, as planned.
At the same time, our research platform has enabled early development and preclinical proof-of-concept of a new family of CB1-SSi with distinct and complementary characteristics to AEF0117 and AEF0217. These new molecules target obesity and associated metabolic disorders, as well as other CB1-related brain diseases.
Thanks to strict resource management, we currently have a solid cash position providing financial visibility beyond 2026, which we intend to extend through additional non-dilutive funding.
We have also launched a very active business development strategy to accelerate the progress of our drug candidates and to strengthen the Company’s financial position. We approach the coming months with a clear roadmap and the ambition to reach new milestones towards establishing Aelis Farma as a leading player in the development of innovative treatments for brain and peripheral diseases.