
Basel, Switzerland – 9 Jan, 2025, Alentis Therapeutics, a clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced positive topline results from two clinical trials of lixudebart (ALE.F02), a monoclonal antibody targeting Claudin-1 (CLDN1), developed to reverse organ fibrosis.
Lixudebart was investigated in two double-blind, placebo-controlled, randomized studies. RENAL-F02 is an ongoing Phase 2 study in Anti-Neutrophil Cytoplasmic Antibody (ANCA) Associated Vasculitis (AAV) with Rapidly Progressive Glomerulonephritis (RPGN) (NCT06047171), where 26 patients have been dosed for up to 24 weeks. FEGATO-01 is a Phase 1b clinical trial where 41 patients with mainly advanced F3/F4 liver fibrosis and/or mild cirrhosis were dosed for up to 4 weeks (NCT05939947).
”The results from the two studies are very encouraging, particularly given the dose-dependent target engagement and favorable safety profile. We also observed an initial decrease in ALT/AST in liver fibrosis patients treated with lixudebart.
Dr. Luigi ManentiChief Medical Officer at Alentis