NFL Biosciences announced that it has submitted a patent application in the United States for its drug candidate NFL-301, focused on reducing alcohol consumption. This patent application submission is a precondition for a pre-IND application with the FDA in the United States1 and a commitment to extending this new patent application internationally. Patent application filed in the United States for the formulation of NFL-301 and commitment to extend it internationally.

NFL Biosciences is continuing to move forward with its intellectual property strategy with the filing of a first patent for NFL-301. It aims to protect prolonged-release formulations of extracts of kudzu, a plant used in traditional Chinese medicine, as well as their uses for the treatment of alcohol consumption reduction. Under the co-development agreement set up at the start of 2022, NFL Biosciences and its industrial partner ATHENA Pharmaceutiques have developed a prolonged-release form of kudzu extracts in microgranule form, NFL-301.

NFL Biosciences aims to develop the first oral delivery drug based on kudzu extracts to tackle excessive alcohol consumption. NFL-301 will stand out from kudzu-based nutritional supplements through: its positioning as a drug that is compliant with marketing authorization (MA) regulations; its dosage that is higher and in line with the expected efficacy range in the countries that limit daily concentrations as a nutritional supplement (e.g. France, Belgium and other European countries); its quality, controlled in accordance with good manufacturing practices (GMP); its prolonged effect enabling a single daily dose; its flexibility for taking and adapting dosage levels due to the microgranule form, compared with capsules or tablets. Preparation of a pre-IND application in the United States for NFL-301: NFL is preparing a pre-IND application in the United States, which is expected to be submitted in September, with a view to obtaining FDA approval for the manufacturing process, product quality and development strategy through to MA.