Pharma Focus America

Alentis' Lixudebart Receives FDA Orphan Drug Designation for the Treatment of Idiopathic Pulmonary Fibrosis

Thursday, May 30, 2024

Alentis Therapeutics, a company specializing in treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to their drug, lixudebart (ALE.F02), for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Alentis, emphasized the urgent need for effective IPF treatment and the completion of necessary studies for their IPF program. He expressed confidence in lixudebart's potential to target CLDN1 in fibrotic lungs with their highly specific antibody.

Prof. Steven Nathan, Medical Director of the Advanced Lung Disease and Transplant Program at Inova Fairfax Hospital, also highlighted the lack of transformative treatment options for IPF patients and the promising safety profile of lixudebart observed in Phase 1 trials.

Orphan Drug designation by the FDA provides certain benefits to sponsors, including tax credits for clinical trials, user-fee exemptions, and potential market exclusivity for seven years post-approval.

Lixudebart (ALE.F02) is a monoclonal antibody designed to address liver, lung, and kidney fibrosis by targeting a specific CLDN1 epitope in fibrotic tissue. Phase 1 studies in healthy volunteers have demonstrated its favorable safety profile. Currently, lixudebart is undergoing clinical trials for advanced liver fibrosis and ANCA-associated vasculitis.

IPF is a rare and severe chronic disease characterized by lung tissue thickening and scarring around the air sacs, leading to breathing difficulties. There is currently no cure for IPF, with existing treatments only able to slow its progression.



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