Aelis Farma launches a Phase 2B clinical trial for AEF0217 in people with Down syndrome

Aelis Farma announced that it has received regulatory approval to begin a Phase 2B clinical trial of AEF0217. This drug is a unique CB1 receptor inhibitor, intended to treat adaptive behavioral and cognitive disorders in people with Down syndrome, a currently unmet medical need.

The trial will include 188 participants aged 16 to 32 in France, Italy, and Spain. This multinational trial aims to confirm the positive results of a previous study. The placebo-controlled study will evaluate the treatment's effectiveness on adaptive behaviors over a 24-week period.

Aelis Farma has taken steps to ensure its financial stability until 2028, in order to support this ambitious trial and the development of its CB1-SSi portfolio. Initial results are expected in mid-2027.