Australia-based CSL and Swiss firm Alentis Therapeutics have entered into an exclusive global collaboration agreement to co-develop and co-promote lixudebart, which has the potential to become a 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.
The collaboration brings together Alentis' scientific expertise as the leading clinical-stage biopharmaceutical company targeting claudin-1 and CSL's global development and commercialisation capabilities in nephrology, with a shared goal of bringing innovative and highly impactful treatment options to patients with rare kidney and liver diseases. In addition to AAV-RPGN, the two companies will 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 $355 million, with Alentis eligible to receive up to an additional $1.2 billion in commercial milestone payments. Once commercialised, global profits will be shared 55 per cent to CSL and 45 per cent to Alentis.