BASEL, Switzerland– Alentis Therapeutics, 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.”
