The Study Evaluates the Pharmacokinetics of ALE.F02 in Advanced Liver Fibrosis Patients
Basel, Switzerland – 13 July 2023, Alentis Therapeutics (“Alentis”), a clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today that the first patient with liver fibrosis has been dosed in the Phase 1b “FEGATO-01” clinical trial of ALE.F02, a CLDN1 targeting investigational antibody for the treatment of liver, kidney, and lung fibrosis.
“ALE.F02 can potentially reverse advanced liver fibrosis,” said Dr. Luigi Manenti, Chief Medical Officer of Alentis. “We have a truly differentiated approach of inhibiting pathologically overexpressed CLDN1 to transform the course of disease in liver, kidney, and lung fibrosis.”
Dr. Roberto Iacone, Chief Executive Officer of Alentis added, “After the completion of a Phase 1 study of ALE.F02 in healthy volunteers earlier this year, I am excited the program now advances to the next phase of development in patients. It is a hopeful moment for the fibrosis community as our technology may address the high unmet medical need of people living with organ fibrosis.”
About the Phase 1b ‘FEGATO-01’ clinical trial
This double-blind placebo-controlled randomized trial is designed to study how the body processes ALE.F02 (pharmacokinetics) in 34 patients with advanced liver fibrosis. Besides primary endpoint PK, secondary endpoints in the trial include safety, pharmacodynamics, target engagement, and further understanding of CLDN1 biology. ClinicalTrials.gov: NCT05939947
ALE.F02 is a first-in-class monoclonal antibody developed to specifically target a unique CLDN1 epitope exposed in fibrotic tissue in order to reverse the disease. ALE.F02 is an investigational antibody that was observed to be well tolerated, with no serious safety concerns, during Phase 1 single- and multiple-ascending dose studies in healthy volunteers.
About Alentis Therapeutics
Alentis Therapeutics, the CLDN1 company, is a clinical-stage biotechnology company 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 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 (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 https://alentis.ch
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