- LAU-7b is safe and well tolerated by adult Cystic Fibrosis (CF) patients
- The pharmacokinetic profile fully achieved the protocol dose selection rationale
- Study drug shows a convergence of multiple promising pharmacodynamic trends
MONTREAL, QC, Canada - June 15th, 2015
Laurent Pharmaceuticals Inc. announced today positive topline results from a Phase 1b clinical trial with LAU-7b in adult CF patients. LAU-7b is a novel oral formulation of fenretinide, a synthetic retinoid investigated for its lipid modulating properties and potential to address the aberrant inflammatory response in CF. The study was conducted at the McGill University Health Centre (MUHC). The trial demonstrated that LAU-7b administrated orally in ascending doses up to 300mg, during three cycles of 21 consecutive days, was safe and well tolerated by adult CF patients. The pharmacokinetic profile of LAU-7 fully achieved the targeted blood levels and dose selection rationale. The treatment also normalized the lipid imbalance and decreased oxidative stress in a vast majority of patients, causing a shift towards an anti-inflammatory pattern particularly at the highest dose tested.