(News Bulletin 247) – The biopharmaceutical company announced this Tuesday the success of a study with the CEA highlighting the cerebral action of NFL-101 on the irrepressible desire to smoke. The stock is soaring on the Paris Stock Exchange.

The start of the year presents itself under the best auspices for NFL Biosciences. The company specializing in the treatment of dependencies and addictions announces a major step in the development of NFL-101, its most advanced drug candidate for smoking cessation.

This Tuesday, the biopharmaceutical company based in Montepellier announced the success of a study carried out in partnership with the Atomic Energy and Alternative Energies Commission concerning NFL-101, its botanical drug candidate for smoking cessation.

Reduced urge to smoke

Initiated in February 2023 and conducted by the CEA pharmacological neuroimaging team, the study highlights the mechanism of action of NFL-101. All three stages of this study have been validated and demonstrate the central effects of NFL-101 treatment, adds NFL Biosciences.

The results of this study demonstrate the ability of NFL-101 to reduce the irrepressible urge to smoke (“craving”) by restoring normal brain activity in the region of the brain associated with this urge. The data also suggest communication between the immune system and the central nervous system, which highlights a different mode of action than current smoking cessation drugs that directly target nicotinic receptors.

“We were able to demonstrate the specific action of NFL-101 on cerebral metabolism in the situation of smoking cessation. These are initial, original and promising results, which open up new perspectives for the treatment and therapeutic monitoring of cessation smoking in humans”, indicates Nicolas Tournier, pharmacologist, radiopharmacist and head of the pharmacological neuroimaging team at the CEA / SHFJ.

On the Paris Stock Exchange, the stock soared by 70% to 2.68 euros after a peak of +100% around 10:30 a.m. in reaction to today’s announcement. The action explores an area that he has not seen since September 2023.

Remember that NFL Biosciences uses natural proteins extracted from tobacco leaves, but devoid of nicotine, as an aid to smoking cessation. NFL-101 is a derivative of a subcutaneous desensitization treatment which had been developed by the Pasteur Institute against allergies in tobacco factory workers. This allergenic extract was then marketed by Stallergenes until 2004 before a change in regulations on allergenic extracts.

With NFL-101, the biopharmaceutical company hopes to help the millions of people around the world who want to stop smoking. And it intends to attack the market for traditional patches and other chewing gums.

The company recalls that NFL-101 has already been tested in two clinical studies: a phase I study (first stage of clinical trials), called Cesto, which confirmed safety and a phase IIa study, Precesto, which confirmed the ability to significantly reduce the satisfaction provided by cigarettes in smokers who do not wish to quit. A phase IIb clinical study, Cesto 2, is underway in nine clinical centers in France on 318 smokers wishing to quit, the results of which are expected in July 2024.

“We intend to continue our work with the CEA, an extension to the study of withdrawal during tobacco/cannabis co-addictions or even in the presence of alcohol is envisaged. The potential of the NFL-201 project, a cannabis extract dedicated to treatment of cannabis addiction, is also reinforced by this discovery”, adds Bruno Lafont, Deputy Managing Director and co-founder of NFL Biosciences.

Alcohol and cannabis: two indications under study

At the same time, NFL Biosciences is developing natural drug candidates for the treatment of two other addictions: that linked to cannabis (NFL-201) and that associated with alcohol (NFL-301). NFL-201 is a mixed extract of tobacco leaf proteins and cannabis proteins (without nicotine, THC or CBD) while NFL-301 aims to reduce alcohol consumption based on a plant extract from traditional Chinese medicine.

Concerning this latest drug candidate, NFL Biosciences filed a pre-IND (Investigational New Drug Application) request in December with the Food and Drug Administration (FDA) – the American health authority – in the United States. This request makes it possible to present to the American health authority the development plan for NFL-301, covering manufacturing and quality control methods, preclinical data and clinical trials.

The company entered the stock market in July 2021 at a price of 3.80 euros, with the ambition of launching a potential blockbuster in the smoking cessation market.