The company plans to file a Phase 2b clinical trial application in mid-2026, aiming to demonstrate efficacy, select the dose, and confirm safety.

 This dose selection study would be conducted in France at around ten clinical centers and would include 450 participants randomized in a double-blind, placebo-controlled trial.

Four doses would be evaluated, with 100 participants for three of them and for the placebo, and 50 participants for a minimum expected dose with no effect.

Two treatment administrations are planned on days 1 and 8. The primary endpoint will be continuous abstinence for 4 weeks, measured between day 15 and day 43 and confirmed by urinary cotinine testing. The visit on day 43 will be the last visit of the study.

An independent Data and Safety Monitoring Board (DSMB) will review safety data after the first 30 participants have been enrolled to authorize further enrollment.