NFL Biosciences, a biopharmaceutical company developing botanical drugs for the treatment of dependencies and addictions, and in particular NFL-101, its drug candidate for smoking cessation, announced its participation in the 16th annual congress of the Société Francophone de Tabacologie (CSFT), these 24 and 25 November in Dijon.
The CSFT 2022 is the flagship event dominating the world of Tobacco in France and in French-speaking countries and of all the actors who revolve around it. More than 350 participants are expected. On this occasion, NFL Biosciences is exhibiting, which will allow it to meet tobacco specialists and healthcare personnel involved in the fight against smoking in order to present to them its drug candidate, NFL-101, with its two ongoing clinical studies ( CESTO II and PRECESTO), and to discuss with the pharmaceutical companies present.
The Francophone Society of Tabacology aims to promote scientific research on tobacco, its use, its consequences on health, as well as on tobacco dependence and related behaviors, and at the same time to facilitate the dissemination and application of this research. and to promote tobacco education. The common thread of the 2022 congress is “tobacco medicine on the front line”.
Bruno Lafont, co-founder and Deputy CEO, will present the various programs developed by NFL Biosciences and will highlight in particular:
NFL-101: a botanical drug candidate from the Institut Pasteur
NFL-101 is a clinically developed botanical drug candidate, composed of natural proteins extracted from tobacco leaves, and free of nicotine. NFL-101 has been the subject of three patent families, as well as preclinical studies and a Phase I which has demonstrated a strong reduction in the desire to smoke, without showing any toxicity. NFL-101 is derived from a subcutaneous desensitization treatment that was developed by the Institut Pasteur against tobacco allergies in tobacco factory workers. Used without prescription by a French doctor on more than 10,000 smokers, the repositioned Institut Pasteur extract had shown promising results which were supported by a retrospective study. NFL-101 is a standardized version for pharmaceutical use.
CESTO II: an ongoing clinical study in 9 clinical investigation centers to demonstrate the effectiveness of NFL-101
CESTO 2 is a Phase II/III clinical study which aims to include 318 smokers in order to demonstrate the effectiveness of NFL-101 against a placebo and to choose the most effective dose. The primary endpoint is the FDA registration endpoint of continuous abstinence for 4 weeks. The follow-up of the patients is 12 months, which makes it possible to measure many other secondary criteria. 9 clinical investigation centers are currently participating in the study, those of the University Hospitals of Bordeaux, Clermont-Ferrand, Dijon, Lorient, Marseille, Montpellier, Poitiers and Rennes, as well as the Eurofins-Optimed research institute in Grenoble. The end of recruitment is scheduled for the first half of 2023.
PRECESTO: a clinical study which will start at the beginning of 2023 in order to highlight the complementarity of NFL-101 with other smoking cessation drugs
PRECESTO is a proof-of-concept clinical study whose main objective is to validate the complementarity of NFL-101 with other smoking cessation treatments and in particular nicotine substitutes (transdermal patches (patches), tablets, chewing gum, inhalers and spray nicotine) for the development of an innovative treatment method combining NFL-101 and other smoking cessation methods. The PRECESTO study will compare NFL-101’s ability to reduce cigarette satisfaction and cravings to placebo in 34 smokers in a cross-over design. Each subject will be his own control and will randomly and alternately receive either NFL-101 or the placebo at the start of each of two periods during which he will evaluate, using international questionnaires, the satisfaction provided by cigarettes and the desire to smoke. The study will be carried out at the Eurofins-Optimed research institute in Grenoble, the first recruitments are planned for early 2023 and the results are expected in the third quarter of 2023.
Source and visual: NFL Biosciences