Australia’s CSL is paying $355 million upfront for the rights to Alentis Therapeutics’ phase 2-stage fibrosis drug.
In return for the rights to co-develop and co-commercialize the anti-Claudin-1 drug, called lixudebart, CSL has also agreed to pay out up to $1.2 billion in commercial milestones if the therapy makes it to market. CSL will be in line for 55% of the overall profits from lixudebart, while Alentis will receive the remaining 45%, according to a release Sunday night.
The Australian pharma has also agreed to fund the completion of Alentis’ ongoing phase 2 study of lixudebart in patients with antineutrophil cytoplasmic antibodies-associated vasculitis who experience rapidly progressive glomerulonephritis (AAV-RPGN). The rare autoimmune disease can cause irreversible damage to the tiny filters inside your kidneys and result in potentially renal disease.
An interim analysis of 26 patients with AAV-RPGN in that mid-stage study demonstrated “promising improvement in kidney function” as assessed by eGFR and proteinuria at 24 weeks, the companies noted.
CSL has also agreed to bankroll a phase 3 trial in AAV-RPGN, as well as planned phase 2 studies in a rare progressive kidney disease called focal segmental glomerulosclerosis and an autoimmune chronic liver disease called primary sclerosing cholangitis.
The protein Claudin-1 is present in the more advanced stage of liver fibrosis and Alentis sees itself as a leader in the field, Alentis’ chief medical officer explained last year when the biotech was named one of Fierce Biotech’s Fierce 15 of 2025. By targeting Claudin-1, lixudebart is designed to reverse organ damage from fibrosis.
“This partnership enables us to dramatically accelerate the development of lixudebart in several indications in parallel,” Alentis CEO Mark Pruzanski, M.D., said in yesterday’s release.
“We are convinced CSL’s demonstrated clinical development and commercialisation capabilities in AAV and kidney diseases makes them the right partner to bring lixudebart to patients,” Pruzanski added.
“More broadly, this furthers the validation of claudin-1 as a novel therapeutic target and we are excited about the potential to accelerate the advancement of our other clinical stage assets and preclinical pipeline,” the CEO added.
CSL—which switched its CEO earlier this year in the wake of a slump in profits—already markets a range of kidney disease meds, including anemia drugs like Mircera and Retacrit, as well as Velphoro to control high blood-phosphate levels and the pruritus treatment Korsuva.
CSL’s Head of R&D Bill Mezzanotte, M.D., said the partnership with Alentis reflects the pharma’s “commitment to building a leading global nephrology franchise, and our strategic intent to create high-value external partnerships.”
“We believe lixudebart has the potential to become an important new therapeutic option to help improve kidney function and prevent progression to end-stage kidney disease, first in AAV-RPGN and hopefully also in focal segmental glomerulosclerosis, while potentially showing similar benefit on liver function in primary sclerosing cholangitis,” Mezzanotte added.
The secret to a successful Big Pharma dealmaking strategy is one of the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below:
