NFL Biosciences, a French biopharmaceutical company, reported positive results from its Phase II clinical trial, CESTO II, evaluating NFL-101 as a smoking cessation treatment. The complete findings were published in Nicotine & Tobacco Research, the official journal of the Society for Research on Nicotine and Tobacco (SRNT). This publication signifies recognition of the study’s results within the scientific community.
The trial, a multicenter, randomized, double-blind, placebo-controlled study with a one-year follow-up, involved 318 smokers. Participants received subcutaneous injections of NFL-101 (100 µg or 200 µg) or a placebo on days one and eight.
The primary endpoint was 28-day continuous abstinence, measured six weeks post-quit. The 100 µg dose of NFL-101 showed a statistically significant increase in continuous abstinence compared to the placebo group. This was confirmed by urinary cotinine levels.
Furthermore, this dose resulted in a significant and sustained decrease in cravings, a key factor in relapse. The drug’s effects were most notable on emotionality and compulsivity related to smoking, suggesting potential for long-term relapse reduction. Abstinent participants also displayed a significant increase in anti-NFL-101 IgG concentrations.
NFL-101 exhibited a safety profile comparable to the placebo. The two-injection regimen, spaced a week apart, promotes treatment adherence.
Bruno Lafont, CEO and co-founder of NFL Biosciences, highlighted the publication as a significant step in enhancing the company’s scientific recognition. He noted ongoing collaborations with institutions like the French Alternative Energies and Atomic Energy Commission (CEA), Hôpital Européen Georges-Pompidou (HEGP), and McLean Hospital.
NFL Biosciences is currently engaging with regulatory agencies to refine the development plan for NFL-101. The company aims to confirm the drug’s efficacy and safety in a larger, international Phase III clinical trial. Discussions with regulators are scheduled for late September.
NFL Biosciences, based in the Montpellier region of France, focuses on developing plant-based drugs to treat addictions. Their lead product, NFL-101, a standardized tobacco leaf extract, is protected by three patent families. The company also develops NFL-301 for alcohol consumption reduction and has a project targeting cannabis use disorders. NFL Biosciences shares are traded on Euronext Growth Paris.
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