CSL and Alentis Therapeutics have entered into an exclusive global collaboration to jointly develop and commercialize lixudebart, an investigational treatment that targets claudin-1 for kidney, liver and other diseases.
Under the agreement, CSL will make an initial payment of $355 million to Alentis. Alentis could also receive up to $1.2 billion in commercial milestone payments. CSL will fund the ongoing development of lixudebart, including clinical trials in kidney and liver diseases.
The companies will jointly develop and co-promote lixudebart, with global profits expected to be shared 55% by CSL and 45% by Alentis once the treatment reaches the market.
Lixudebart is currently being studied in the Phase 2 RENAL trial in patients with ANCA-associated vasculitis with rapidly progressive glomerulonephritis (AAV-RPGN). This is a rare autoimmune disease that can cause a rapid loss of kidney function and may lead to irreversible kidney damage or end-stage kidney disease.
The drug is designed to target claudin-1, a protein involved in maintaining the structure and function of tissues. Alentis believes blocking claudin-1 could produce both anti-inflammatory and anti-fibrotic effects, potentially helping prevent or reverse organ damage.
Beyond AAV-RPGN, CSL and Alentis plan to develop lixudebart for focal segmental glomerulosclerosis (FSGS), a rare kidney disease that can progressively damage the kidneys. The companies will also study the drug in primary sclerosing cholangitis (PSC), a chronic autoimmune liver disease that damages the bile ducts.
CSL will fully fund the completion of the ongoing Phase 2 RENAL study and a planned Phase 3 trial in AAV-RPGN. The company will also fund planned Phase 2 studies in FSGS and PSC, along with other supporting development activities.
Alentis CEO Mark Pruzanski said the partnership will allow the companies to advance lixudebart across several indications at the same time. He added that the deal further supports claudin-1 as a potential new therapeutic target.
CSL said the collaboration strengthens its strategy to build a global nephrology business. Bill Mezzanotte, EVP and Head of R&D at CSL, said lixudebart could potentially provide a new treatment option for patients with AAV-RPGN and help prevent progression to end-stage kidney disease.
The partnership also gives Alentis access to CSL’s global clinical development and commercialization capabilities. For CSL, the deal expands its pipeline in rare kidney diseases while adding a potential treatment that could eventually address kidney and liver conditions.
If successful, lixudebart could become a first-in-class claudin-1-targeting therapy across multiple diseases with significant unmet treatment needs.