Basel, Switzerland – 26 April 2023, Alentis Therapeutics, a clinical-stage biotechnology company, has announced the 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 involved 24 subjects, with 18 receiving the active drug and six receiving a placebo across three dose levels, administered every two weeks.
Dr. Luigi Manenti, Chief Medical Officer at Alentis, highlighted the study's significance as the first to target CLDN1 in humans, noting ALE.F02's good safety and tolerability across multiple dose levels. He emphasized the absence of serious adverse events and the achievement of desired pharmacokinetics, confirming the concentrations necessary for extracellular remodeling were met.
Dr. Manenti also discussed the pharmacodynamics, stating that the trial not only confirmed the on-target biological activity observed in the single-ascending dose (SAD) study from the previous June but also saw this activity enriched in the MAD part of the trial.
Dr. Roberto Iacone, CEO of Alentis Therapeutics, expressed satisfaction with the trial's outcomes, stating that the successful conclusion validates Claudin-1 as a safe target. With ALE.F02 being safe and well tolerated, Alentis is poised to advance platform and indication expansion, moving forward with first-in-patient liver and renal studies this year.
Alentis Therapeutics is dedicated to developing breakthrough treatments for CLDN1+ tumors and organ fibrosis, pioneering a novel approach to modify and reverse disease progression by targeting CLDN1. Founded in 2019, the company is based on groundbreaking research from the University of Strasbourg and the French National Institute of Health (Inserm), with headquarters in Basel, Switzerland, and an R&D subsidiary in Strasbourg, France, along with clinical operations in the US.
