Tuesday, June 18, 2024

Pulmonary Fibrosis Treatment: Alentis Granted FDA Orphan Drug Designation for Lixudebart

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

Dr. Luigi Manenti, Chief Medical Officer of Alentis, commented, “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.”

Pulmonary Fibrosis: Prof. Steven Nathan Praises Alentis’ Efforts in Developing Lixudebart for IPF Treatment

Prof. Steven Nathan, Medical Director of the Advanced Lung Disease and Transplant Program at Inova Fairfax Hospital, added, “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. 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 grants orphan status to drugs or biologics intended to prevent, diagnose, or treat rare diseases or conditions. Orphan Drug designation qualifies sponsors for several incentives, including tax credits for qualified clinical trials, user-fee exemptions, and a potential seven years of market exclusivity after approval.

Lixudebart is a first-in-class monoclonal antibody developed to treat 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 being tested in clinical trials for advanced liver fibrosis (NCT05939947) and ANCA-associated vasculitis (NCT06047171).

Pulmonary Fibrosis

Pulmonary Fibrosis: Understanding IPF’s Impact on Lung Tissue and the Urgent Need for Effective Treatments

Idiopathic Pulmonary Fibrosis (IPF) is a rare and serious chronic disease affecting the tissue surrounding the air sacs (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, and existing treatments only slow the progression of IPF.

Alentis Therapeutics, known as 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 diseases. Alentis is pioneering the development of anti-CLDN1 antibodies and antibody-drug conjugates (ADCs) to modify and reverse the course of these diseases.

Alentis Therapeutics has received FDA Orphan Drug designation for lixudebart (ALE.F02), a first-in-class monoclonal antibody targeting Claudin-1 (CLDN1), for the treatment of Idiopathic Pulmonary Fibrosis (IPF). This designation underscores the significant need for effective IPF treatments. Lixudebart has shown promise in Phase 1 trials, exhibiting a favorable safety profile, and is now advancing into further clinical testing. The FDA’s Orphan Drug designation provides various incentives, including tax credits and potential market exclusivity, which could accelerate the development and availability of lixudebart for IPF patients. With no current cure for IPF and limited treatment options, lixudebart represents a potential breakthrough in managing this debilitating disease. Alentis Therapeutics continues to lead in developing innovative treatments targeting CLDN1, addressing unmet needs in cancer and fibrotic diseases.

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Resource: Businesswire, May 29, 2024

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