The collaboration leverages Alentis’ scientific focus on claudin-1 and CSL’s established global footprint in nephrology. Under the agreement, Alentis receives an initial payment of US$355 million, with the potential for an additional US$1.2 billion tied to commercial milestones. CSL will take responsibility for fully funding the ongoing Phase 2 RENAL trial and future Phase 3 development, as well as upcoming studies for focal segmental glomerulosclerosis and primary sclerosing cholangitis. Once the drug reaches the market, the two companies will share global profits on a 55-45 split.
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CSL and Alentis Partner to Develop Lixudebart for Rare Organ Diseases
CSL and Alentis Therapeutics have entered a global partnership to co-develop and market lixudebart, a first-in-class therapy targeting claudin-1. The deal, valued at up to US$1.55 billion, aims to address severe kidney and liver conditions, including ANCA-associated vasculitis, where patients currently face a high risk of permanent organ damage.
Lixudebart acts as a monoclonal antibody designed to block inflammatory and fibrotic pathways. Clinical data from the RENAL trial and the earlier FEGATO study suggest the drug can improve markers of kidney and liver function while maintaining a favorable safety profile. According to Dr. Mark Pruzanski, CEO of Alentis, the partnership allows the firm to accelerate development across multiple indications simultaneously. Dr. Bill Mezzanotte, head of R&D at CSL, noted that the move is part of a broader strategy to build a leading global nephrology franchise, positioning lixudebart as a critical intervention for patients who often progress to end-stage disease despite existing treatments.
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