NFL BIOSCIENCES (Euronext Growth Paris – FR0014003XT0 – ALNFL), a biopharmaceutical company developing botanical drugs for the treatment of dependencies and addictions, announces that it has today filed a pre-IND application with the FDA in the United States for its drug candidate NFL -301, dedicated to reducing excessive alcohol consumption. This approach aims to formalize the NFL-301 development program and constitutes an essential preliminary step to establish the optimum clinical development plan.
In accordance with the initial strategy presented during the IPO, NFL Biosciences is progressing in the development of two drug candidates. On the one hand, NFL-101, a tobacco extract administered subcutaneously, targets smoking cessation and is in phase 2b clinical study on 318 subjects, with main results expected for July 2024. On the other hand, NFL-301, a purified kudzu extract administered orally to reduce excessive alcohol consumption, achieves another significant milestone with the filing of a pre-IND application to the FDA following the patent application filed in July 2023 .
This pre-IND application is an essential step, allowing us to present to the FDA the development plan for NFL-301, covering manufacturing and quality control methods, preclinical data and clinical trials.