tobacco leaf extract (NFL-101) / NFL Biosci - LARVOL DELTA

Efficacy and Safety of NFL-101 as a Smoking Cessation Therapy: A Randomized Phase II Clinical Trial CESTO2. (PubMed, Nicotine Tob Res) - P2 | "In this multicenter randomized clinical trial that included 318 smokers, effect sizes between groups were sufficiently large to suggest a meaningful clinical effect. NFL-101 at a dose of 100 μg increased 6-week post-quit 28-day continuous smoking abstinence that was confirmed by urinary cotinine concentrations and reduced craving, suggesting psychological benefits that could mitigate relapse risks. Abstainers experienced a significant increase in anti-NFL-101 IgG concentrations compared to those who continued to smoke.Findings from the present study offer support for an entirely new category of treatment that acts through immune modulation. Additional strengths include a subcutaneous route of administration in the form of two injections spaced a week apart (thus, enhances treatment adherence) and has demonstrated a safe profile with minimal adverse effects. These results support a follow up Phase III clinical trial."

Clinical • Journal • P2 data • CNS Disorders • Immune Modulation • Immunology • Psychiatry • Tobacco Addiction • Tobacco Cessation

CESTO2: Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy (clinicaltrials.gov) - P2 | N=318 | Completed | Sponsor: NFL Biosciences SAS | Recruiting ➔ Completed

Trial completion • Nicotine Addiction • Tobacco Cessation

Multi-peptide characterization of plasma neurofilament light chain in preclinical and mild Alzheimer's disease. (PubMed, Brain Commun) - "We observed elevated neurofilament light chain in preclinical Alzheimer's disease plasma for two measures (NfL101 and NfL324) and CSF for seven measures (NfL92, NfL101, NfL117, NfL137, NfL148, NfL165 and NfL530). We found five plasma peptides (NfL92, NfL101, NfL117, NfL324 and NfL530) significantly associated with age and two (NfL148 and NfL324) with body mass index."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders • Dementia • NEFL • Plasma NfL

Brain Glucose Metabolism as a Readout of the Central Nervous System Impact of Cigarette Smoke Exposure and Withdrawal and the Effects of NFL-101, as an Immune-Based Drug Candidate for Smoking Cessation Therapy. (PubMed, ACS Chem Neurosci) - "In tobacco research, [18F]FDG PET imaging provides a quantitative method to evaluate changes in the brain function associated with the withdrawal phase. This method also showed the CNS effects of NFL-101, with translational perspectives for future clinical evaluation in smokers."

Journal • Tobacco Cessation

CESTO2: Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy (clinicaltrials.gov) - P2 | N=318 | Recruiting | Sponsor: NFL Biosciences SAS | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Sep 2023 ➔ Jul 2024

Trial completion date • Trial primary completion date • Nicotine Addiction • Tobacco Cessation