NFL Biosciences announces that its Phase II / III clinical study, designed to evaluate the efficacy and safety of its NFL-101 treatment as a smoking cessation therapy, has been approved by the National Agency for Drug Safety and Health. health products (ANSM), and has received the favorable opinion of the Committee for the Protection of Persons (CPP). The NFL-101 Phase II / III study involves 318 patients. It had already been approved in Australia at the end of May 2021, a country targeted by NFL Biosciences for the quality of its clinical trials and its competitive research tax credit. Thanks to this approval, NFL will be able to recruit patients in France, initially in the Clinical Investigation Centers (CIC) of Poitiers, Bordeaux and Rennes.
The trial will be multicenter, randomized, double-blind versus placebo. It will include 3 arms (two dose arms and one placebo arm) and patient follow-up will be 12 months. The main objectives of CESTO II are to select the best dose and to assess the effectiveness of NFL-101 compared to placebo, for immediate cessation of smoking and also for gradual cessation. The main endpoints are continuous abstinence for 4 weeks (FDA criterion, Food & Drug Administration, United States) and 6 months (EMA criterion, European Medicines Agency). The biomarkers used to confirm abstinence are exhaled carbon monoxide and urinary cotinine. Many secondary endpoints will also be assessed, such as the number of cigarettes smoked, withdrawal symptoms and craving.
The administration of the treatment consists of a first subcutaneous injection, concomitant with an attempt to quit smoking, followed a week later by a second injection. The goal is to facilitate success in the days following a quit attempt, an essential time to greatly increase the chances of long-term success. An optional injection may be offered at month three as well as at month six for patients who were not abstinent on these dates and who undertake to make a new attempt to stop at each injection. The aggregate efficacy at the end of treatment, after two, three or four injections will also be measured, assessing the potential for personalization of the treatment.