NFL Biosciences: Decision Expected in November for NFL-102 Phase 2 Trial
NFL Biosciences provided an update on October 6, 2026 on its two smoking cessation candidates, NFL-101 and NFL-102. The company detailed the timeline for several scientific publications, one of which is intended to support the search for a partner for NFL-101.
Two Manuscripts in Preparation, Including One on NFL-101 Biomarker
The post hoc analysis of data from the CESTO2 study on the predictive biomarker of NFL-101 efficacy has been completed. A group of authors bringing together experts from McLean Hospital / Harvard Medical School in Boston, the Centre for Addiction and Mental Health (CAMH) in Toronto and the Georges-Pompidou European Hospital in Paris is finalizing a manuscript. Its submission to an international peer-reviewed scientific journal is planned in the coming days.
According to the company, the publication of these results, after independent peer review, will broaden their scientific visibility and support licensing discussions with pharmaceutical laboratories. NFL-101, whose efficacy and tolerability were evaluated in a phase 2 trial, is being developed using a precision medicine approach based on this biomarker, which identifies patients most likely to respond to treatment. The candidate is preparing for a phase 3 trial and is intended to be the subject of a licensing agreement.
On mechanisms of action, the CEA is finalizing a manuscript presenting results of brain imaging and proteomics, with submission planned in October. In addition, McLean Hospital / Harvard Medical School is conducting a preclinical microdialysis study in mice, which measures neurotransmitters released in different brain regions. The company received initial positive results in late September; work is continuing and a dedicated announcement will be published once these results are consolidated.
NFL-102: Responses Submitted to ANSM and CPP for TONIC Trial
The authorization file for the TONIC phase 2 trial, which is to evaluate NFL-102, was submitted in late July 2026. As part of the usual review procedure, the National Agency for the Safety of Medicines and Health Products (ANSM) and the Committee for the Protection of Persons (CPP) addressed questions to NFL Biosciences. The company responded to them and, provided no new questions are raised, expects a decision in November 2026.
The study is to recruit 310 smokers in order to evaluate the tolerability and efficacy of NFL-102 and determine its optimal dose. An initial analysis will focus on the first 40 participants as soon as their data becomes available.
The two candidates, derived from tobacco leaves, target complementary biological mechanisms involved in addiction. They are designed to be administered as two subcutaneous injections one week apart.
