NFL Biosciences tackles withdrawal with drug from tobacco

Proteins extracted from tobacco leaves… for smoking cessation. NFL Biosciences, which develops botanical drugs to treat dependencies and addictions, has just obtained approval in Australia for a phase II study for its drug candidate NFL-101, as a smoking cessation therapy.

Nicotine-free, it presents no toxicity and generates “an immediate reduction in the urge to smoke, noticeable the same day or the next day.” However, the sooner the smoker succeeds, the more likely he is to become abstinent, ”explains Bruno Lafont, Deputy CEO. Injected subcutaneously, NFL-101 can be administered at any time, alone or in combination with existing treatments. It has been the subject of the filing of two patent families.

Ten years of research

Why Australia? “The virtual disappearance of Covid-19 in this country allows clinical studies to take place over a period of twenty-four months and on a panel of 318 smokers,” replied Bruno Lafont. A phase II study on 204 patients, first approved in France in 2020, had been blocked by the health crisis. The objective is to sign licensing agreements with pharmaceutical laboratories in 2024 or 2025. The conduct of phases II and III will eventually generate a financing requirement “of around 3 million euros”, projects t -he.

This phase II is the culmination of ten years of research. Indeed, NFL-101 is the derivative of a desensitization treatment developed by the Institut Pasteur against tobacco allergies in factory workers. It was marketed as an allergen by Stallergenes until 2004. It was also used without medical prescription for the purpose of smoking cessation by Jean-Pierre Nicolas, a French anesthetist, on more than 10,000 smokers.

A prospective, uncontrolled study highlighted a 56% efficacy rate at six months and 44% at one year, on 290 patients. In 2010, NFL Biosciences acquired this know-how from Stallergenes to develop it in smoking cessation. The preclinical studies and phase I, carried out with the Montpellier Cancer Institute, confirmed the effectiveness of the treatment with 33% at six months out of 24 patients. NFL Biosciences has other botanical drug projects for cannabis use disorders and alcoholism.