NFL-101 aiming to cure tobacco addiction with unmatched efficiency
NFL-101 is a patented, botanical drug candidate that aims at increasing the odds of quitting for smokers willing to quit.
NFL-101 is a natural product based on a standardized extract of tobacco leaf.
Unlike side-effects prone chemical compound varenicline (Champix® / Chantix®), that acts on ubiquitous receptors in the brain, muscle and other tissues, or unlike nicotine replacement therapy (patches, gums, sprays, lozenges) or more recently e-cigarettes, both delivering in significant quantities of the addictive agent - nicotine, NFL-101 contains only minute amounts of nicotine and is composed of well-characterized, natural tobacco leaf proteins.
NFL-101 is delivered via two simple subcutaneous injections, administered one week apart at a Target Quit Date, making patient compliance a breeze. Two additional, optional injections are made available to patients still not abstinent at month three and six.
Following the creation of NFL Biosciences, a Scientific Advice from the European Medical Agency (EMA) guided manufacturing standardization. Preclinical studies' results have been approved by the French Agency for Drug Safety (ANSM). A Phase I/II clinical trial (CESTO, NCT02521701) that reported NFL-101 data in 2017 and that was implemented at the Montpellier Cancer Institute (ICM) confirmed safety and efficacy in smokers willing and trying to quit, in terms of total cessation at twelve months as well as reduction without compensatory over-smoking. A second patent was filed in 2016. A Phase II/III clinical study has been approved in France where it is currently ongoing on 318 volunteers.
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