Alentis Therapeutics Declares positive results from phase 1 multiple-ascending dose cohorts study

Alentis Therapeutics (Alentis), a clinical-stage biotechnology company developing novel treatments for organ fibrosis and CLDN1+ tumours, announced results from its first-in-human phase 1 clinical study of ALE.F02 targeting Claudin-1 (CLDN1). The trial included 24 participants: 18 were given the active drug and six were given a placebo at three different dose levels. Doses were given to participants every two weeks.

"This study is the first to target CLDN1 in humans," said Dr. Luigi Manenti, chief medical officer at Alentis. At multiple dose levels, ALE.F02 demonstrated good safety and tolerability. There were no serious incidents, and there were no dose delays or reductions." Dr. Manenti went on to say that the pharmacokinetics data confirmed the desired exposures, specifically that the concentrations needed for extracellular remodelling were met. 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.” Alentis Therapeutics, the Claudin-1 (CLDN1) company, is a clinical-stage biotechnology company that focuses on developing breakthrough treatments for CLDN1+ tumours and organ fibrosis.