Lixudebart

The study evaluates the safety and renal sparing efficacy of lixudebart BASEL, Switzerland--(BUSINESS WIRE)-- Alentis Therapeutics (“Alentis”), a clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, today announced the first patient dosed in a Phase 2 clinical trial of lixudebart (formerly named ALE.F02), a Claudin-1 (CLDN1) targeting investigational antibody for the treatment of organ fibrosis. The randomized, double-blind, placebo-controlled Phase 2 study (NCT06047171) of lixudebart evaluates the drug’s safety, tolerability, pharmacokinetics, and how well it protects against the loss of kidney function. The study plans to recruit patients with Antineutrophil Cytoplasmic Antibody (ANCA)-associated vasculitis with Rapidly Progressive Glomerulonephritis (RPGN). This disease typically causes a rapid and dramatic loss of kidney function and can result in kidney loss with patients requiring dialysis or a transplant. While current treatments can eventually stabilize the underlying disease (‘vasculitis’), there’s a need to specifically protect against the severe and dramatic kidney loss that occurs while awaiting stabilization. “With lixudebart (ALE.F02) we explore a truly novel approach in ANCA-RPGN patients. It is the second clinical trial investigating lixudebart in patients after the initiation of a clinical study in advanced liver fibrosis patients earlier this year,” said Dr. Luigi Manenti, Chief Medical Officer of Alentis. “The ANCA-RPGN trial is a steppingstone to develop lixudebart for other more common renal indications that are characterized by high CLDN1 expression such as lupus nephritis​, IgA nephropathy​ and diabetic nephropathy.” Per Ivarsen, Clinical Professor and Principal Investigator of the trial at Aarhus University Hospital in Denmark added, “Dosing the first patient in the study at our hospital brings us a step closer to understanding the potential of lixudebart (ALE.F02) to treat patients with this very severe renal disease. I am looking forward to the study progressing as more patients are enrolled, and to seeing the results of the study.” David Jayne, Professor of Clinical Autoimmunity at Cambridge University said, “This is an important study into the potential of lixudebart (ALE.F02) to recover kidney function in patients with severe nephritis due to ANCA-associated vasculitis. Chronic and end-stage kidney disease remain common outcomes for patients, and this study will give us our first indication on the safety and efficacy of lixudebart in this population.” About lixudebart (ALE.F02) Lixudebart, formerly named ALE.F02, is a first-in-class monoclonal antibody developed for liver, lung and kidney fibrosis. It specifically targets a unique CLDN1 epitope exposed in fibrotic tissue to stop progression and even reverse disease. Lixudebart is an investigational antibody that was well tolerated and without any serious safety concerns in a Phase 1 single- and multiple-ascending dose study in healthy volunteers. About ANCA-RPGN ANCA-associated vasculitis with rapidly progressive glomerulonephritis (ANCA-RPGN) is a rare, severe and potentially fatal disease. RPGN is characterized by rapid loss of kidney function over a very short period (days to weeks). Despite potent immunosuppressive treatment, most patients develop significant or total loss of kidney function. About Alentis Therapeutics Alentis Therapeutics, the CLDN1 company, is a clinical-stage biotech developing breakthrough treatments for CLDN1+ tumors and organ fibrosis. Alentis is the leading company pioneering a novel approach to modify and reverse the course of disease by targeting CLDN1, a previously unexploited target that plays a key role in the pathology of cancer and fibrotic disease. Alentis was founded in 2019 based on ground-breaking research in the laboratory of Prof. Thomas Baumert, MD at the University of Strasbourg and the French National Institute of Health and Medical Research (Inserm). Alentis is headquartered in pharma-biotech hub Basel, Switzerland with an R&D subsidiary in Strasbourg, France and clinical operations in the US. Visit

The trial confirms ALE.F02’s good safety profile, exposure and target biological activity BASEL, Switzerland--(BUSINESS WIRE)-- Alentis Therapeutics (“Alentis”), the clinical-stage biotechnology company developing breakthrough treatments for organ fibrosis and CLDN1+ tumors, today announced results from the multiple-ascending dose (MAD) part of its first-in-human Phase 1 clinical study of ALE.F02 targeting Claudin-1 (CLDN1). The trial enrolled 24 subjects: 18 received the active drug and six received placebo across three dose levels. Participants were dosed every two weeks. Dr. Luigi Manenti, Chief Medical Officer at Alentis said: “This study is the first to target CLDN1 in humans. ALE.F02 showed good safety and tolerability at multiple dose levels. There were no serious events and no dose delays or reductions.” Dr. Manenti added that the pharmacokinetics data confirmed the desired exposures, specifically, that the concentrations required for extracellular remodeling were achieved. Speaking to the pharmacodynamics, Dr. Manenti said, “We not only confirmed the evidence of on-target biological activity that we witnessed in our single-ascending dose (SAD) study last June, but we also saw this enriched in the MAD part of the trial.” “We achieved what we set out to do in both the SAD and MAD studies,” said Dr. Roberto Iacone, CEO of Alentis Therapeutics. “The successful conclusion of this trial validates that Claudin-1 is a safe target. With ALE.F02 being safe and well tolerated, Alentis can progress platform and indication expansion. This puts us in a strong position as we advance to the next phase of development starting with first-in-patient liver and renal studies this year.” About Alentis Therapeutics Alentis Therapeutics, the Claudin-1 (CLDN1) company, is a clinical-stage biotechnology company that focuses on developing breakthrough treatments for CLDN1+ tumors and organ fibrosis. Alentis is pioneering a novel approach to modify and reverse the course of disease progression targeting CLDN1, a previously unexploited target that plays a key role in the pathology of tumors with immune evasive properties and fibrotic disease across multiple organs. Alentis is the only company developing potential treatments for solid cancers and fibrosis targeting CLDN1. The company was founded in 2019 based on ground-breaking research in the laboratory of Prof. Thomas Baumert MD at the University of Strasbourg and the French National Institute of Health (Inserm). Alentis is headquartered in Basel’s pharma-biotech hub in Switzerland with an R&D subsidiary in Strasbourg, France and clinical operations in the US. Visit View source version on businesswire.com: Contacts For more information please contact: Alentis Therapeutics Nathalie Graf-Tschupp info@alentis.ch O public relations GmbH O’Patrick Wilson o@os-pr.com Tel: +41 (0) 78 888 4332 Source: Alentis Therapeutics View this news release online at: