NFL Biosciences (Euronext Growth Paris:ALNFL), a biopharmaceutical company developing botanical drugs for the treatment of addictions, on Tuesday announced positive results from an extended toxicity study confirming the safety and tolerability of NFL-101, its first-in-class treatment for tobacco addiction.

The study assessed daily administration of NFL-101 at doses up to 630 times the cumulative clinical dose in animal models, with no signs of systemic or local toxicity.

Compared to existing treatments, the maximum cumulative doses safely evaluated for nicotine, cytisine and varenicline were significantly lower, reinforcing NFL-101's superior safety profile. Genotoxicity and mutagenicity studies also showed no deleterious effects on DNA or genetic mutations at the highest tested doses.

These findings further strengthen NFL-101's benefit-risk ratio and support ongoing regulatory discussions for a Phase 3 development plan. The Phase 2 CESTO II trial previously demonstrated NFL-101's efficacy comparable to varenicline (Champix) and superior to nicotine substitutes.

NFL Biosciences continues industrial development efforts to produce GMP batches for Phase 3 trials, positioning NFL-101 as a potential safe and effective alternative for tobacco addiction treatment.