» On Tobacco Free Month, NFL Biosciences Presents Ongoing Clinical Studies to Help Smokers Quit MyPharma Editions

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NFL Biosciences Highlights Ongoing Clinical Studies To Help Smokers Quit In Celebrating Tobacco Free Month

Posted on Tuesday, November 15, 2022

NFL Biosciences, a biopharmaceutical company developing botanical drugs for the treatment of dependence and addiction, and in particular NFL-101, a drug candidate for smoking cessation currently in Phase II/III clinical study in France, fully subscribes to the message and Tobacco Free Month initiatives in France in November 2022. NFL Biosciences is a partner of Tobacco Free Month.

Nearly 33% of French people aged 12 to 75, or about 17 million people, said they had already used tobacco and ¼ of them said they smoked every day. France is in 10th place in the European ranking relating to the number of smokers. While 57% of smokers say they want to quit, only 4% of attempts are ultimately successful.

Committed for more than 10 years to clinical research for the treatment of addictions, NFL Biosciences has developed NFL-101, a botanical drug candidate for smoking cessation which is currently the subject of two clinical studies: CESTO II and PRECESTO.

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. 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.

Smokers can be candidates for the clinical trial by contacting the clinical investigation center closest to them. For some clinical centers, it is also possible to volunteer via the website www.cesto2.com.

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 the ability of NFL-101 to reduce the satisfaction caused by cigarettes and the urge to smoke with a placebo in 34 smokers.

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.

Bruno Lafont, co-founder and Deputy CEO of NFL Biosciences concludes: “Tobacco is a global scourge and France is not spared: smoking-related care costs around 26 billion Euros per year to the French State. , i.e. €1,800 per citizen. The 18 million annual tax receipts mentioned by the OFDT (French Observatory of Drugs and Drug Addiction) do absolutely nothing to balance the scales. All of us, individually and collectively, public authorities, companies and civil society, we must do our part and subscribe to initiatives in favor of the fight against smoking and its disastrous consequences. At NFL Biosciences, the fight against addictions and dependence is our raison d’être and we have chosen to develop innovative and botanical drugs to help people who want to quit smoking, it is at this level that our expertise plays a driving role in meeting these challenges for future generations”.

Source and visual: NFL Biosciences

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