Australian biopharma company CSL Limited (ASX:CSL) (USOTC:CSLLY) and Swiss biotechnology company Alentis Therapeutics announced on Sunday that they have entered into an exclusive global collaboration agreement to co-develop and co-promote lixudebart, a potential first-in-class therapy targeting claudin-1 across a range of kidney, liver and other diseases.

Lixudebart is currently being evaluated in the ongoing Phase 2 RENAL trial in patients with ANCA (antineutrophil cytoplasmic antibodies)-associated vasculitis with rapidly progressive glomerulonephritis (AAV-RPGN), a rare and potentially life-threatening autoimmune disease that can cause irreversible kidney damage and end-stage renal disease.

With a novel mechanism of action, lixudebart exerts potent anti-inflammatory and anti-fibrotic effects to potentially prevent and reverse organ damage in ANCA-associated vasculitis (AAV) and numerous other kidney, liver and lung diseases. The ongoing phase 2 trial is designed to translate these mechanistic effects into meaningful clinical impact.

In addition to AAV-RPGN, the two companies plan to advance lixudebart as a novel treatment for focal segmental glomerulosclerosis (FSGS), a rare progressive kidney disease, and for primary sclerosing cholangitis (PSC), an autoimmune chronic liver disease.

Under the agreement, CSL and Alentis will jointly develop and co-promote lixudebart. CSL will make an initial payment to Alentis of USD355m, with Alentis eligible to receive up to an additional USD1.2bn in commercial milestone payments. Additionally, CSL will fully fund the completion of the ongoing Phase 2 RENAL trial and planned Phase 3 trial in AAV-RPGN, the Phase 2 trials in FSGS and PSC and other supporting development activities. Once commercialised, global profits will be shared 55% to CSL and 45% to Alentis.