CSL, Alentis Partner to Commercialize Lixudebart for Rare Kidney, Liver Diseases

Editor’s Take: Lixudebart’s novel mechanism of action has the potential to prevent or even reverse organ damage.

CSL and Alentis Therapeutics have a global collaboration to develop and promote lixudebart to treat kidney, liver, and other diseases.

Under the agreement, CSL is making an initial $355 million payment to Alentis. Alentis will then be eligible to receive up to $1.2 billion more in commercial payments.

What is Lixudebart?

Lixudebart is a potential first in class therapy targeting claudin-1, a key driver of inflammatory and fibrotic signaling paths in various diseases.

A Phase II trial is studying lixudebart in patients with antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis with rapidly progressive glomerulonephritis (AAV-RPGN).

AAV-RPGN, a rare autoimmune disease, can cause permanent kidney damage and end-stage renal disease. Lixudebart’s novel mechanism of action allows it to potentially prevent or even reverse organ damage.

Alentis and CSL Leaders React

“This enables us to dramatically accelerate development of lixudebart in several indications in parallel,” Alentis CEO Mark Pruzanski, MD, said. “We are convinced CSL’s demonstrated clinical development and commercialization capabilities in AAV and kidney diseases makes them the right partner. More broadly, this furthers the validation of claudin-1 as a novel therapeutic target. We are excited about the potential to accelerate the advancement of our other clinical stage assets and preclinical pipeline.”

“Patients with AAV-RPGN face rapid kidney function decline,” CSL Executive Vice President and Head of R&D Bill Mezzanotte, MD, said. “[This leaves] them at risk of irreversible damage even with currently available treatments. We believe lixudebart has the potential to become an important new therapeutic option to help improve kidney function … Our partnership with Alentis reflects CSL’s commitment to building a leading global nephrology franchise.”

In addition to AAV-RPGN, CSL and Alentis plan to advance lixudebart to treat focal segmental glomerulosclerosis and primary sclerosing cholangitis.

CSL will fully fund the end of the ongoing Phase II trial, plus a planned Phase III trial, in AAV-RPGN. The company is also funding Phase II trials in the other conditions listed above. Alentis and CSL will share global profits.