NFL Biosciences Receives Green Light to Launch Phase 2 TONIC Trial in Smoking Cessation
NFL Biosciences announced on October 22, 2026, that it has obtained authorizations from the ANSM and the Committee for the Protection of Persons (CPP) to launch the Phase 2 TONIC trial, dedicated to its candidate NFL-102 in smoking and nicotine cessation. First patient inclusions are scheduled for November 2026, and analysis of results from the first part of the study is expected in April 2027, two milestones that will each be the subject of a dedicated announcement.
An Adaptive Trial on 310 Smokers, From Three Doses to One
The TONIC study plans to recruit 310 smokers in France as part of a multicenter, randomized, double-blind, placebo-controlled trial. Its adaptive design should make it possible to progressively select one dose among the three initially tested. The primary efficacy endpoint is continuous abstinence for four weeks, confirmed by urinary cotinine measurement.
Part A involves the first 40 participants enrolled at the Eurofins Optimed clinical center in Gières. At the end of this phase, one dose will be discontinued based on tolerability and efficacy data, analyzed after unblinding by an independent data monitoring committee (IDMC) and by the company.
Part B plans the inclusion of 150 additional participants (50 per arm, divided between the two retained doses and placebo) across approximately ten centers in France. An interim analysis conducted by the IDMC will then designate the most effective dose, without unblinding for other participants. The trial will then continue with this single dose versus placebo, with 120 additional participants (60 per arm).
According to the company, NFL-102 targets "a root cause of addiction": alterations in brain plasticity.
Cash Position for Part A, Partners Sought for Continuation
NFL Biosciences indicated that its current cash position allows it to finance Part A of the TONIC trial. To ensure clinical development of Part B, the company is actively pursuing efforts to identify strategic and financial partners.
The group is developing in parallel a second candidate, NFL-101, presented as a distinct immunotherapy aimed at reducing neuroinflammation. According to the press release, NFL-101 demonstrated statistical significance in a Phase 2 trial in a population defined by a predictive immune biomarker of response, identified through post-hoc analyses.
A manuscript presenting these results is under submission to an international peer-reviewed scientific journal. NFL-101 is being prepared for a Phase 3 trial and is intended to be the subject of a licensing agreement. Both candidates, derived from tobacco leaves, are designed to be administered as two subcutaneous injections one week apart.
