NFL BIOSCIENCES announced the inclusion of the first volunteer in its PRECESTO clinical trial, designed to evaluate the complementarity of its NFL-101 treatment as a smoking cessation therapy with other smoking cessation treatments, notably nicotine replacement therapies. This Phase IIa clinical study, entitled PRECESTO, was approved by the French National Agency for the Safety of Medicines and Health Products (ANSM), and received a positive opinion from the French Committee for the Protection of Individuals (CPP) in November 2022. Its main objective is to validate the complementarity of NFL-101 with other smoking cessation treatments, in particular nicotine substitutes (transdermal patches, tablets, gum, inhalers and nicotine sprays), with a view to developing an innovative treatment method combining NFL-101 with other smoking cessation methods.

PRECESTO is being implemented at Eurofins Optimed's clinical research center in Gières, in the Grenoble area. In this new treatment method, for which a patent was filed in October 2022, the administration of NFL-101 prior to the quit attempt aims to break the link between cigarettes and the satisfaction they provide, and to reduce the desire to smoke. Smokers can then focus on their quit attempt and manage their nicotine withdrawal symptoms (irritability, nervousness, anxiety, etc.) with the help of other smoking cessation treatments, including nicotine replacement therapies.

The PRECESTO study compares the ability of NFL-101 to reduce cigarette satisfaction and craving with placebo. It is a randomized, double-blind study that will include a total of 34 smokers who do not wish to quit and have high smoking satisfaction in a cross-over design. Each subject is his or her own control and receives either NFL-101 or placebo randomly and alternately at the beginning of each of two periods during which he or she assesses satisfaction with cigarettes and craving for cigarettes using international questionnaires.

The periods are each one month long. The Modified Cigarette Evaluation Questionnaire (mCEQ) is used as the main instrument. It measures satisfaction with smoking, psychological reward, aversion, pleasant sensations in the airways, and reduction in craving.

Results of the PRECESTO study are expected in the third quarter of 2023. This study is expected to increase the attractiveness of NFL-101 to pharmaceutical companies marketing smoking cessation drugs and who may be interested in licensing it.