Alentis Reports Positive Results from Lixudebart Studies in ANCA-RPGN and Advanced Liver Fibrosis

BASEL, Switzerland, January 09, 2025 – Alentis Therapeutics, a clinical-stage biotechnology firm, has reported promising results from two clinical trials involving its drug lixudebart (ALE.F02). This monoclonal antibody, aimed at reversing organ fibrosis, targets Claudin-1 (CLDN1) and is being developed for conditions such as Claudin-1 positive tumors and organ fibrosis.

The clinical trials conducted were double-blind, placebo-controlled, and randomized. One trial, RENAL-F02, is an ongoing Phase 2 study focused on patients with ANCA-Associated Vasculitis, particularly those experiencing Rapidly Progressive Glomerulonephritis (RPGN). In this study, 26 patients have received doses over a 24-week period. The second trial, FEGATO-01, involved a Phase 1b clinical evaluation of 41 patients with advanced liver fibrosis, mainly F3/F4 stages or mild cirrhosis, over a four-week dosing period.

The trials demonstrated dose-dependent target engagement, a crucial factor in drug efficacy. Lixudebart showed a favorable safety profile, and patients tolerated it well. Luigi Manenti, Chief Medical Officer of Alentis, expressed optimism about the results, particularly highlighting the observed decrease in liver enzyme levels (ALT/AST) in patients suffering from liver fibrosis.

In addition, interim findings from the RENAL-F02 study suggested that lixudebart may contribute positively to the recovery of Glomerular Filtration Rate (GFR) and a reduction in proteinuria among patients with ANCA-RPGN. David Jayne, a Professor of Clinical Autoimmunity at Cambridge University, noted that these improvements were further supported by reductions in CD163, a validated urinary biomarker. This indicates an impact on immune cell movement and localization within the kidney.

The safety profile of lixudebart was consistent across both trials, whether administered as a standalone treatment or alongside standard care. This consistency extends the favorable safety results from an earlier Phase 1 clinical trial involving healthy volunteers, where no significant safety concerns were raised.

Lixudebart stands as a pioneering monoclonal antibody specifically developed for addressing fibrosis in organs such as the liver, lung, and kidney. By targeting a distinct CLDN1 epitope found in fibrotic tissues, the drug aims to reverse the fibrotic processes. Earlier Phase 1 studies on healthy individuals revealed that lixudebart was well-tolerated, with no major safety issues. The drug has also obtained Orphan Drug designation from the FDA for treating Idiopathic Pulmonary Fibrosis (IPF).

Alentis Therapeutics is at the forefront of developing first-in-class antibody-drug conjugates and antibodies targeting Claudin-1 for both cancer and multi-organ fibrosis. Claudin-1 has emerged as a significant yet previously untapped target in the treatment of cancer and fibrotic diseases. Alentis is a leader in developing CLDN1-targeted therapies that aim to alter and potentially reverse disease trajectories. The company's lead ADC program, ALE.P02, has received Fast Track designation from the FDA for treating advanced or metastatic CLDN1+ squamous cancers, regardless of the cancer's origin.

Founded on the innovative research conducted at the University of Strasbourg and the French National Institute of Health and Medical Research, Alentis maintains its headquarters in Basel, Switzerland. It also has an R&D subsidiary in Strasbourg, France, and conducts clinical operations in the United States.