Efficacy and Safety of NFL-101 as a Smoking Cessation Therapy: A Randomized Phase II Clinical Trial CESTO2
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.
Authors
- Isabelle Ingrand (ORCID: https://orcid.org/0000-0002-2709-1585)
- Éric Tartour (ORCID: https://orcid.org/0000-0002-7323-468X)
- Hugues Chevassus (ORCID: https://orcid.org/0000-0001-8145-671X)
- Yannick Plétan
- Claire Lafay‐Chebassier (ORCID: https://orcid.org/0000-0001-8970-5514)
- Gisèle Pickering (ORCID: https://orcid.org/0000-0001-9054-9379)
- Mathilde Latreille
- Liliya Chamitava (ORCID: https://orcid.org/0000-0003-1020-3293)
- Nadine Benhamouda (ORCID: https://orcid.org/0000-0002-0438-924X)
- Anastasia Demina (ORCID: https://orcid.org/0000-0001-7694-6618)
- Yves Donazzolo (ORCID: https://orcid.org/0009-0002-4314-607X)
- Pierre‐Olivier Girodet (ORCID: https://orcid.org/0000-0002-9298-9711)
- Fabrice Lainé (ORCID: https://orcid.org/0000-0001-6405-2211)
- Jean-Sébastien Allain
- Bruno Lafont
- Marie-Laure Fraisse
- Julie Balland
Institutions
- Délégation Paris 5 (FR)
- European Organisation for Rare Diseases (FR)
- Solid State Physics Laboratory (IN)
- Inserm (FR)
- Université de Bourgogne (FR)
- Université Paris Cité (FR)
- Université de Poitiers (FR)
- Associazione Italiana Sclerosi Multipla (IT)
- Centre Hospitalier Universitaire de Montpellier (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Centre Hospitalier de Bretagne Sud (FR)
- Clinical Investigation Center Plurithematic Tours (FR)
- Hôpital Européen Georges-Pompidou (FR)
- Bordeaux Population Health (FR)
- Centre Hospitalier Universitaire de Poitiers (FR)
- CIC Rennes (FR)
- Hôpital Pontchaillou (FR)
- Conseil Régional de Nouvelle-Aquitaine (FR)
- Universidad del Valle (NI)
- Centre Hospitalier Universitaire de Clermont-Ferrand (FR)
- Institute for Neurosciences of Montpellier (FR)
- Maison des Sciences sociales et des Humanités de Dijon (FR)
- OZ Biosciences (France) (FR)
- Services déconcentrés d'appui à la recherche Occitanie-Montpellier (FR)
- Centre de Recherche Cardio-Thoracique de Bordeaux (FR)
- Centre Hospitalier Universitaire de Rennes (FR)
- Ridge Lea Hospital (GB)
Publication Details
- Journal
- Nicotine & Tobacco Research
- Published
- 2025-08-29
- DOI
- https://doi.org/10.1093/ntr/ntaf181
- Primary Topic
- Smoking Behavior and Cessation
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Institut National de la Santé et de la Recherche Médicale
- Centre National de la Recherche Scientifique
- Centre Hospitalier Régional Universitaire de Montpellier
- École Normale Supérieure de Lyon
- Centre Hospitalier Universitaire de Rennes