LAU-7b is a novel and improved solid dosage form of fenretinide, requiring. once-a-day oral administration. LAU-7b was recently tested in adult patients with CF in a dose-ascending Phase 1b study, showing a good safety and tolerability, and promising pharmacokinetic and pharmacodynamic results. More information about the Phase 1b trial can be found at: www.clinicaltrials.gov (NCT02141958).
The study population involved in the Phase 1b trial was previously characterized in a non-interventional, natural history study, which explored the predictive value for pulmonary exacerbation and response to antibiotic treatment during exacerbations of systemic lipidomic, inflammation and oxidation biomarkers. Data collected from the non-interventional study was used to compare the response to exacerbation antibiotic treatment of these markers to plasma levels obtained in Phase 1b. The study drug normalized the plasma levels of AA and DHA in the vast majority of patients, causing a shift towards an anti-inflammatory and pro-resolving pattern, particularly during pulmonary exacerbation.
Laurent Pharmaceuticals is currently recruiting patients for its Phase 2 safety and efficacy study in adult patients with CF. The goal of the Phase 2 trial is to evaluate LAU-7b’s effect on the preservation of lung function, by reducing persistent unresolved inflammation in the lung and stimulating its return to homeostasis. The study will enroll 136 adults with CF for a treatment duration of 6 months and will involve more than 30 clinical sites in USA and Canada.
Radzioch 2018 - Fenretinide prevents the development of age-related lung disease in CFTR-knockout mice and overproduction of MUC5AC