NFL Biosciences: Phase II / III clinical study of NFL-101 for smoking cessation approved in France
The Phase II / III clinical study, entitled CESTO II, was approved by the ANSM and received the favorable opinion of the CPP
The CESTO II study, already approved in Australia at the end of May 2021, becomes an international study involving 318 patients
NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing botanical drugs for the treatment of dependencies and addictions, announcement What are they study clinique of Phase II/III, destined to évaluis the effectiveness and safety ofe his treatment NFL-101 as therapy smoking cessation, has been approved through l” National Agency for the Safety of Medicines and Health Products (ANSM), and 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 Biosciences 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 a placebo arm) and patient follow-up will be 12 months. The main objectives of CESTO II are to select the best dose and to evaluate 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, which is essential 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.
« We are very satisfieds of cahead news approbation clinical trial on France. The approach international of this essay is the basis of our development future of which the goal is from to return NFL-101 available atx 780 million smokers whom the World Health Organization believes want to quit. Tobacco use is in effect a global scourge and pread ¾ of smokers helped fail Again in theirs tentatives stop. NFL-101 show To offer smokers real support in the treatment of their addiction and is positioned as a major advance in the field of struggle against this particularly stubborn addiction Said Bruno Lafont, Deputy CEO and co-founder of NFL Biosciences.
About NFL Biosciences
NFL Biosciences is a biopharmaceutical company based in the Montpellier region whose most advanced botanical drug candidate is a smoking cessation aid. 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, long-term effective, short administration and personalized alternative.
Beyond NFL-101, NFL Biosciences has plans to develop botanical drugs for the treatment of cannabis use disorders and alcoholism.
NFL Biosciences shares are listed on Euronext Growth Paris (FR0014003XT0 – ALNFL). More information on www.nflbiosciences.com
Bruno Lafont – firstname.lastname@example.org – 04 11 93 76 67
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