About NFL Biosciences
NFL Biosciences seeks to help cure major addictions through a breakthrough approach based on botanical pharmaceutical agents.
Our company clinically develops NFL-101, a patented, botanical drug candidate that aims at increasing the odds of quitting for smokers willing to quit.
Our goal is to apply our scientific approach to other drug candidate with an initial focus targeting the growing addiction to cannabis.
Revolutionizing smoking cessation
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 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.
There exists vast anecdotal evidence, from more than 10,000 smokers treated off-label in France with a predecessor product developed by the Pasteur Institute, that NFL-101 is safe and efficacious for long term smoking cessation.
A Phase I/II clinical trial confirmed safety and efficacy in smokers willing and trying to quit, in terms of long-term total cessation as well as reduction without compensatory over-smoking. We are launching a multicentric, double blind, placebo controlled +300-patient Phase II(/III) clinical trial.
It was initially developed by the Pasteur Institute in France as an allergenic extract used for the desensitization of tobacco factories' workers suffering from allergies to the manipulation of tobacco leaves.
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.