NFL Biosciences: CESTO II trial progressing on schedule
January 20 2023 - 1:00AM
NFL Biosciences: CESTO II trial progressing on schedule
NFL Biosciences: CESTO II trial progressing on
schedule
Nine clinical sites active: more than 72% of the
clinical trial participants recruited
Main results expected by the end of 2023
NFL BIOSCIENCES (Euronext Growth Paris –
FR0014003XT0 – ALNFL), a biopharmaceutical company that is
developing botanical drugs for the treatment of addictions, is
announcing that the CESTO II Phase II/III clinical trial to assess
the efficacy and safety of its NFL-101 smoking cessation treatment
is progressing in line with the set
schedule
CESTO II is a placebo-controlled Phase II/III
clinical trial that aims to include 318 smokers and choose the most
effective dose. Nine clinical investigation sites are currently
involved in the trial: the CHU teaching hospital centers in
Bordeaux, Clermont-Ferrand, Dijon, Lorient, Marseille, Montpellier,
Poitiers and Rennes, as well as the Eurofins-Optimed research
institute in Grenoble. With 232 subjects recruited to date, NFL
Biosciences expects to finalize recruitments during the second
quarter, which would enable results to be obtained for the main
criteria at the end of 2023.
CESTO II’s objectives are to select the best
dose and assess the efficacy of NFL-101 versus placebo. The primary
end-point for assessment is the subjects’ continued abstinence for
four weeks (US Food & Drug Administration (FDA) accepted
end-point). Many other secondary end-points will also be assessed,
including the subjects’ continued abstinence for six months
(European Medicines Agency (EMA) accepted end-point), the number of
cigarettes smoked, withdrawal symptoms and level of craving.
NFL-101: a botanical drug candidate from
Institut Pasteur
NFL-101 is a clinically developed, nicotine-free
botanical drug candidate, comprising natural proteins extracted
from tobacco leaves. NFL-101 is covered by three patent families
and has been subject to preclinical and Phase I trials,
highlighting a significant reduction in the desire to smoke,
without any toxicity. NFL-101 is derived from a subcutaneous
desensitization treatment that had been developed by Institut
Pasteur for tobacco allergies among people working in tobacco
factories. Used on an over-the-counter basis by a French doctor
with over 10,000 smokers, the repositioned Institut Pasteur extract
showed promising results, substantiated by a retrospective study.
NFL-101 is a standardized version for pharmaceutical use.
About NFL Biosciences
NFL Biosciences is a biopharmaceutical company
based in the Montpellier area which develops botanical drug
candidates for the treatment of addictions. NFL Biosciences'
ambition is to bring new, natural, safer and more effective
therapeutic solutions to the entire world population, including
low- and middle-income countries. Its most advanced product, called
NFL-101, is a standardized, nicotine-free tobacco leaf extract
protected by two patent families. NFL Biosciences intends to offer
smokers who want to quit a natural, safe, easy-to-administer and
personalized alternative. NFL Biosciences is also developing
NFL-301, a natural drug candidate for the reduction of alcohol
consumption and has a drug development project for the treatment of
cannabis use disorders.
The shares of NFL Biosciences are listed on
Euronext Growth Paris (FR0014003XT0 – ALNFL). Find out more at
www.nflbiosciences.com
Contacts
Bruno Lafont – info@nflbiosciences.com - +33 4
11 93 76 67 Agence
Calyptus – nflbio@calyptus.net - +33 1 53 65 68 68
- 20230123_NFLBioscience_CP_Avancement-CESTO-II_EN_DEF
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