Australian biopharmaceutical leader CSL and Swiss clinical-stage biotechnology company Alentis Therapeutics have entered into an exclusive global partnership agreement to co-develop and co-promote lixudebart (formerly ALE.F02), an investigational, potential first-in-class monoclonal antibody targeting claudin-1 across multiple rare fibrotic and inflammatory organ diseases.
Under the terms of the agreement, CSL will make an upfront payment of US355 million to Alentis, with Alentis eligible to receive up to an additional US1.2 billion in commercial milestone payments, alongside a 55/45 global profit-sharing structure (55% to CSL and 45% to Alentis) upon successful commercialization. CSL will fully fund the completion of the ongoing Phase II RENAL trial, a planned pivotal Phase III trial in ANCA-associated vasculitis with rapidly progressive glomerulonephritis (AAV-RPGN), as well as Phase II clinical development in focal segmental glomerulosclerosis (FSGS) and primary sclerosing cholangitis (PSC).
Lixudebart is designed to selectively bind exposed claudin-1, a key driver of inflammatory and fibrotic signaling pathways. By producing dual anti-inflammatory and anti-fibrotic activity, the biologic aims to halt scar tissue buildup and prevent progression to irreversible organ failure. In an interim analysis of 26 patients with AAV-RPGN enrolled in the Phase II RENAL trial, lixudebart demonstrated meaningful improvements in kidney function at 24 weeks. The therapy has also demonstrated clinical engagement and improved liver markers in the Phase IbFEGATO study, while holding FDA Orphan Drug designation for idiopathic pulmonary fibrosis.
Bill Mezzanotte, Executive Vice President and Head of R&D at CSL, noted that lixudebart offers a promising therapeutic strategy to arrest loss of organ function and improve long-term outcomes for patients facing end-stage renal disease. Mark Pruzanski, Chief Executive Officer of Alentis Therapeutics, emphasized that partnering with CSL leverages their global clinical infrastructure and nephrology expertise to accelerate lixudebart’s multi-indication clinical development.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
