Lixudebart (ALE.F02) is a first-in-class monoclonal antibody in clinical development for multi-organ fibrosis

Alentis Therapeutics (“Alentis”), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today that the U.S. Food and Drug Administration (FDA) has granted lixudebart (ALE.F02) Orphan Drug designation for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Dr. Luigi Manenti, Chief Medical Officer of Alentis said, “The Orphan Drug designation for lixudebart underscores the urgent medical need for an effective IPF treatment. We have completed IND-enabling studies for our IPF program, and we strongly believe that targeting CLDN1 in fibrotic lungs with our highly specific antibody has the potential to reverse the course of the disease.”

“IPF patients do not have transformative treatment options and often experience tolerability challenges with the current standard of care drugs. Alentis is doing important work on developing lixudebart as a treatment targeting the root causes of disease,” added Prof. Steven Nathan, Medical Director of the Advanced Lung Disease and Transplant Program at Inova Fairfax Hospital. “This molecule has shown a very favorable safety profile in Phase 1, and I would be thrilled to see lixudebart tested in IPF patients in the future.”

The FDA provides orphan status to drugs or biologics to prevent, diagnose or treat a rare disease or condition. Orphan Drug designation qualifies sponsors for certain incentives, including tax credits for qualified clinical trials, user-fee exemptions and a potential seven years of market exclusivity after approval.

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 observed to be well tolerated, with no serious safety concerns. Lixudebart is currently tested in clinical trials for advanced liver fibrosis (NCT05939947) and ANCA-associated vasculitis (NCT06047171).

About IPF

Idiopathic pulmonary fibrosis, or IPF, is a rare and serious chronic disease affecting tissue surrounding the air sacs or alveoli in the lungs, resulting in the thickening of lung tissue. Over time, this thickening causes permanent scarring of the lungs, called fibrosis, which makes breathing increasingly difficult. There is currently no cure for this condition with treatments only slowing the progression of IPF.

About Alentis Therapeutics

Alentis Therapeutics, the CLDN1 company, is a clinical-stage biotech developing breakthrough treatments for CLDN1+ tumors and 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 anti-CLDN1 antibodies and ADCs to modify and reverse the course of disease.

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 https://alentis.ch

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