NFL Biosciences SA announced that it has significantly increased efficacy targets for its smoking cessation drug candidates. Additional exploratory analyzes conducted on a sample of CESTO2 study participants indicate that subjects with certain characteristics have significantly higher rates of sustained abstinence than those observed in the entire study population. These preliminary results, based on analyzes of a sample of approximately 60 participants, will need to be refined by analyzing the characteristics of all participants in the CESTO2 study.
Currently available data suggest an efficacy of between 35% and 60% in a subpopulation that represents approximately one third of the general population. Please note that the efficacy in terms of continuous abstinence for 4 weeks, confirmed by the cotinine urinary test, was 24.1% in the general population, significantly higher than placebo and comparable to currently available treatments. The order of prescription may depend on the validation of the predictive biomarker associated with NFL-101 and the level of clinical efficacy demonstrated by NFL-102 in the general population.
A strengthened clinical development strategy based on recent findings. Initially, the company planned to continue the clinical development of NFL-101 through a two-part Phase 3 study: a first part aimed at confirming the efficacy observed in the Phase 2 CESTO2 study, followed by a second part intended to validate the efficacy in the general population, with approximately 900 participants and a 12-month follow-up period. Given its recent results, the company is now implementing a strengthened and more efficient clinical development strategy based on two complementary drug candidates, NFL-101 and NFL-102, without impacting overall development time.
NFL-101 aims to reduce smoking-induced functional inflammation and has already demonstrated its clinical efficacy in the Phase 2 CESTO2 study. Comprehensive analysis of the discriminant characteristics of all participants in this study, expected in the coming months, will confirm both the superior level of efficacy observed and the size of the target subpopulation. The company plans to submit a Phase 2b clinical trial application in mid-2026, with the goal of demonstrating efficacy, selecting dosing and confirming safety.
Extension of intellectual property rights to 2047. The composition of NFL-102 was the subject of a new patent application filed in January 2026, which extends the intellectual property protection to 2047 and also broadens the scope to other addictions beyond tobacco and nicotine, including alcohol, psychostimulants, opioids and cannabinoids. The results of the proteomic study on CREB, and cannabinoids. The results of the proteomic study on CREB are expected in the first half of 2026, and the second part aims to validate the efficacy in the general population.
