Robust Dose-Dependent Target Engagement Demonstrated by Lixudebart in Both Studies
Preliminary Evidence of Improvement in Organ Function: eGFR and Proteinuria in ANCA-RPGN, and ALT/AST in Liver Fibrosis
Lixudebart Exhibited a Favorable Safety Profile and was Well-Tolerated
BASEL, Switzerland I January 09, 2025 I Alentis Therapeutics (“Alentis”), 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,” said Luigi Manenti, Chief Medical Officer. “We also observed an initial decrease in ALT/AST in liver fibrosis patients treated with lixudebart.”
“Interim results from the RENAL-F02 study in ANCA-RPGN indicate beneficial effects of lixudebart on Glomerular Filtration Rate (GFR) recovery and proteinuria reduction,” said David Jayne, Professor of Clinical Autoimmunity at Cambridge University. “These observations were further supported by reductions of CD163, a validated urinary biomarker, also indicating an impact on immune cell homing and trafficking to the kidney.”
In both clinical trials, lixudebart demonstrated a favorable safety profile, both as a monotherapy and in combination with standard of care (n=51 active patients across the two trials). These findings are consistent with the safety results from the Phase 1 clinical trial of lixudebart in healthy volunteers (n=48 active patients).
About Lixudebart (ALE.F02)
Lixudebart is a first-in-class monoclonal antibody developed for liver, lung and kidney fibrosis. The investigational antibody is designed to reverse organ fibrosis by specifically targeting a unique CLDN1 epitope exposed in fibrotic tissue. In Phase 1 single- and multiple-ascending dose studies in healthy volunteers, lixudebart was well tolerated, with no serious safety concerns. Lixudebart has been granted Orphan Drug designation by the FDA for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
About Alentis Therapeutics
Alentis Therapeutics is a clinical-stage biotechnology company pioneering first-in-class antibody-drug conjugates (ADCs) and antibodies targeting Claudin-1 (CLDN1) for oncology and multi-organ fibrosis. CLDN1 is a previously unexploited target that plays a key role in the pathology of cancer and fibrotic disease. Alentis is the leading company pioneering CLDN1 ADCs and antibodies to modify and reverse the course of select diseases. The FDA granted Fast Track designation to the lead ADC program, ALE.P02, for the treatment of advanced or metastatic CLDN1+ squamous cancers, irrespective of the organ of origin.
Alentis was founded 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 at the pharma-biotech hub in Basel, Switzerland, with an R&D subsidiary in Strasbourg, France, and clinical operations in the US. Visit www.alentis.ch
SOURCE: Alentis Therapeutics
Post Views: 147
Robust Dose-Dependent Target Engagement Demonstrated by Lixudebart in Both Studies
Preliminary Evidence of Improvement in Organ Function: eGFR and Proteinuria in ANCA-RPGN, and ALT/AST in Liver Fibrosis
Lixudebart Exhibited a Favorable Safety Profile and was Well-Tolerated
BASEL, Switzerland I January 09, 2025 I Alentis Therapeutics (“Alentis”), 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,” said Luigi Manenti, Chief Medical Officer. “We also observed an initial decrease in ALT/AST in liver fibrosis patients treated with lixudebart.”
“Interim results from the RENAL-F02 study in ANCA-RPGN indicate beneficial effects of lixudebart on Glomerular Filtration Rate (GFR) recovery and proteinuria reduction,” said David Jayne, Professor of Clinical Autoimmunity at Cambridge University. “These observations were further supported by reductions of CD163, a validated urinary biomarker, also indicating an impact on immune cell homing and trafficking to the kidney.”
In both clinical trials, lixudebart demonstrated a favorable safety profile, both as a monotherapy and in combination with standard of care (n=51 active patients across the two trials). These findings are consistent with the safety results from the Phase 1 clinical trial of lixudebart in healthy volunteers (n=48 active patients).
About Lixudebart (ALE.F02)
Lixudebart is a first-in-class monoclonal antibody developed for liver, lung and kidney fibrosis. The investigational antibody is designed to reverse organ fibrosis by specifically targeting a unique CLDN1 epitope exposed in fibrotic tissue. In Phase 1 single- and multiple-ascending dose studies in healthy volunteers, lixudebart was well tolerated, with no serious safety concerns. Lixudebart has been granted Orphan Drug designation by the FDA for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
About Alentis Therapeutics
Alentis Therapeutics is a clinical-stage biotechnology company pioneering first-in-class antibody-drug conjugates (ADCs) and antibodies targeting Claudin-1 (CLDN1) for oncology and multi-organ fibrosis. CLDN1 is a previously unexploited target that plays a key role in the pathology of cancer and fibrotic disease. Alentis is the leading company pioneering CLDN1 ADCs and antibodies to modify and reverse the course of select diseases. The FDA granted Fast Track designation to the lead ADC program, ALE.P02, for the treatment of advanced or metastatic CLDN1+ squamous cancers, irrespective of the organ of origin.
Alentis was founded 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 at the pharma-biotech hub in Basel, Switzerland, with an R&D subsidiary in Strasbourg, France, and clinical operations in the US. Visit www.alentis.ch
SOURCE: Alentis Therapeutics
Post Views: 147
