CSL strikes $1.6B deal with Alentis for experimental kidney, liver drug

CSL (CSLLY) agreed to pay Alentis Therapeutics $355 million upfront as part of a global partnership to develop lixudebart, an experimental antibody being studied for serious kidney and liver diseases.

Under the agreement, Alentis could receive up to another $1.2 billion in commercial milestone payments. CSL will also fund the completion of the ongoing Phase 2 RENAL trial and a planned Phase 3 study in ANCA-associated vasculitis with rapidly progressive glomerulonephritis, or AAV-RPGN. The companies will jointly develop and promote lixudebart, with CSL receiving 55% of global profits and Alentis getting 45%.

For investors, the agreement gives CSL access to a clinical-stage drug that could expand its nephrology business while shifting much of the scientific and clinical risk to future trial results. The $355 million upfront payment represents CSL's immediate financial commitment, while the additional $1.2 billion depends on commercial milestones. CSL will, however, bear the costs of several clinical trials, increasing its investment if development advances.

Lixudebart is a monoclonal antibody targeting exposed claudin-1, which is involved in inflammatory and fibrotic signaling. Alentis is initially studying the drug in AAV-RPGN, a rare autoimmune disease that can cause rapid and irreversible kidney damage. The companies also plan development programs in focal segmental glomerulosclerosis, a progressive kidney disease, and primary sclerosing cholangitis, a chronic liver disease.

Alentis reported that an interim analysis of 26 patients in the Phase 2 RENAL study showed improvements in measures of kidney function after 24 weeks. An earlier Phase 1b study involving 41 patients with advanced liver fibrosis also showed improved liver function after six weeks. Those findings are preliminary, and lixudebart has not yet demonstrated efficacy in a pivotal Phase 3 trial.

CSL said the partnership fits its strategy of expanding its kidney-disease portfolio, while Alentis said CSL's funding and development infrastructure should allow it to pursue several indications simultaneously. Lixudebart has also received FDA Orphan Drug designation for idiopathic pulmonary fibrosis, although that indication was not identified as a primary focus of the collaboration.