NFL Biosciences: launch of the Phase II / III clinical study for smoking cessation
An international study conducted on 318 smokers over a forecast period of 24 months
4 centers open simultaneously in France and Australia
Inclusion of patients from January 2022
NFL Biosciences TO, biopharma companyceutical developant botanical drugs for the treatment of dependencies and addictions, officially launches its Phase II / III clinical study, titled CESTO II, intended to evaluate the efficacy and safety of its NFL-101 treatment as a smoking cessation therapy. Approved by the Human Research Ethics Committee (HREC) in Australia (cf press release of June 2, 2021) and by the National Medicines Safety Agency (ANSM) (cf press release September 15th 2021), CESTO II will include his first patients from January 2022 in the 4 centers open clinics.
Bruno Lafont, Deputy CEO and co-founder of NFL Biosciences: « We are happy to take this new step important in our CESTO II study. Le choice of’inclure les premiers patients in january should allows to capitalize on the good resolutions taken by smokers to the news year. The main objective of these tests, which will take place in 4 centers, 3 in France and 1 in Australia, is to demonstrate that NFL-101, natural drug candidate the most innovative among them in advanced clinical development, could constitute a leading solution giving smokers wishing to quit smoking, real support in the treatment of their addiction. “
A STUDY INTERNATIONAL SIZE AND APPROVED MAIN CRITERIA.
The CESTO II Phase 2/3 clinical trial will be multicenter, randomized, double-blind versus placebo. The test is carried out as follows:
- 3 arms (two dose arms and one placebo arm);
- 318 smokers, aged 18 and over;
- 12-month patient follow-up (CESTO2, NCT04571216);
- Subjects will receive two initial subcutaneous injections one week apart. Additional booster injections are possible at 3 and 6 months for patients not abstaining on these dates;
- Clinical Center of the University of Tasmania in Australia and Clinical Investigation Centers (CIC) of Poitiers, Bordeaux and Rennes in France
REMINDER OF THE MAIN OBJECTIVES OF CESTO II
The main objectives of this study 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 endpoints are continuous abstinence for 4 weeks (FDA) and 6 months (EMA). 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.
ABOUT NFL-101: A BOTANICAL DRUG CANDIDATE A FORT POTENTIAL
NFL-101 is a clinically developed botanical drug candidate composed of natural proteins extracted from tobacco leaves, and devoid of nicotine. NFL-101 was the subject of the filing of two families of patents, as well as preclinical studies and a Phase I which demonstrated a strong reduction in the desire to smoke, without exhibiting toxicity.
NFL-101 is derived from a subcutaneous desensitization treatment that had been developed by the Pasteur Institute against tobacco allergies in workers in tobacco factories. Used without prescription by a French doctor on more than 10,000 smokers, the repositioned Pasteur extract had shown promising results which were supported by a retrospective study. NFL-101 is a standardized version for pharmaceutical use. A Phase II / III study of 318 patients became an international study following the approval by the ANSM and the favorable opinion of the CPP in September 2021.
About NFL Biosciences
NFL Biosciences is a Montpellier-based biopharmaceutical company developing a botanical drug candidate for smoking cessation. Called NFL-101, this natural product, extracted from standardized tobacco leaves and devoid of nicotine, is protected by two families of patents. NFL Biosciences intends to offer smokers who wish to quit a natural, safe, simplified and personalized alternative.
Beyond NFL-101, NFL Biosciences has plans to develop botanical drugs for the treatment of cannabis use disorders and alcoholism.
Bruno Lafont – email@example.com – 04 11 93 76 67
Calyptus Agency – firstname.lastname@example.org – 01 53 65 68 68