French biopharmaceutical company NFL Biosciences (Euronext Growth Paris:ALNFL) announced on Thursday that has received approval from France's National Agency for Medicines and Health Products Safety (ANSM) and the Committee for the Protection of Human Subjects (CPP) to begin its Phase 2 TONIC trial evaluating NFL-102 for smoking and nicotine cessation.

The multicentre, randomised, double-blind, placebo-controlled study plans to enrol 310 smokers in France and will use an adaptive design to select the most effective dose from three initial candidates. The primary endpoint is continuous abstinence for four weeks, confirmed by urinary cotinine.

Part A will assess the first 40 participants at the Eurofins Optimed Clinical Center in Gières, with enrolment scheduled to begin in November 2026 and results expected in April 2027. Based on safety and efficacy data, one dose will be eliminated following an analysis by an Independent Data Monitoring Committee and the company.

Part B will involve additional participants across approximately 10 clinical centres in France, with an interim analysis guiding the selection of the final dose for comparison with placebo.

NFL Biosciences said its current cash position is sufficient to fund Part A, and it is seeking strategic and financial partners to support the clinical development of Part B.

NFL-102 targets changes in brain plasticity associated with addiction, while the company's separate candidate, NFL-101, is designed to reduce neuroinflammation and has demonstrated statistically significant efficacy in a Phase 2 trial in a subgroup identified through post-hoc immune biomarker analyses.