NFL Biosciences has secured green lights from French regulators to launch a Phase 2 trial of its smoking-cessation candidate, targeting 310 participants in a randomized, double-blind study against placebo.
The Montpellier-based biopharmaceutical firm announced it received clearances from the Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the Comité de protection des personnes (CPP) to begin the TONIC trial, evaluating NFL-102 for smoking and nicotine cessation, Boursier.com reported.
Evaluating Brain Plasticity and Dosing Strategies in the TONIC Trial
While NFL Biosciences’ other candidate, NFL-101, focuses on reducing neuroinflammation and a manuscript presenting these results is in course of submission to an international peer-reviewed scientific journal, NFL-102 aims directly at a root cause of addiction: alterations in brain plasticity. NFL-101 has shown a clearly significant efficacy in Phase 2 in a population defined by an immune biomarker predictive of response, identified in post-hoc analyses. The trial design uses an adaptive approach to test three initial doses across 310 smokers in France. The primary endpoint measures continuous abstinence over four weeks, verified via urinary cotinine testing. Both treatments are designed to be administered in two subcutaneous injections one week apart. The intellectual property of the company includes five patent families, and its shares are listed on Euronext Growth Paris under the ticker ALNFL (ISIN: FR0014003XT0).
Part A of the trial will examine the first 40 participants treated at the Eurofins Optimed clinical center in Gières. An independent data monitoring committee (IDMC) and the company will review safety and efficacy data, lifting the blind to eliminate the least viable dose. Boursier.com noted that current company cash reserves cover the funding required for Part A. Both of these steps will be the subject of dedicated communications, as indexed by NFL Biosciences.
Clinical Timeline and Part B Development Plans
Initial patient inclusions are scheduled to begin in November 2026, with the analysis of Part A results anticipated in April 2027. Following those milestones, Part B—comprising the following 270 participants—will introduce 150 additional participants (meaning 50 per arm randomized between the two retained dose arms and the placebo) across roughly ten French clinical sites.
The trial will continue with the inclusion of 120 additional participants (meaning 60 per arm randomized between the selected dose and the placebo) assigned to either the chosen dose or a placebo. To fund the expansion into Part B, NFL Biosciences is actively pursuing its efforts aimed at identifying strategic and financial partners in order to ensure the clinical development of Part B, according to Boursier.com. NFL-101 is developed within a personalized medicine approach based on a biomarker associated with treatment response and is intended to be the subject of a licensing agreement for Phase 3, while NFL-102 is developed up to clinical proof of concept with the TONIC study.
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