Novartis today announced it will pay $3.2B to acquire Chinook Therapeutics, a Seattle-based biopharmaceutical company with two late-stage medicines in development for rare, severe, chronic kidney diseases, including Immunoglobulin A Nephropathy (IgAN). Such drugs are the vanguard of targeted therapy for IgAN.

As Selvaskandan  et al. wrote in one recent paper, “For the first time, effective treatment options beyond supportive care are becoming available for those with IgAN. …future challenges will revolve around deciding which treatments are most appropriate for individual patients, which is likely to push IgAN into the realm of precision medicine.”

This deal is “fully in line with Novartis strategy to focus on innovative medicines and will significantly expand its renal portfolio, complementing the existing pipeline,” the big pharma said in a press release. The transaction is expected to close in the second half of 2023.

“IgA Nephropathy is a devastating disease mostly affecting young adults and potentially leading to dialysis or kidney transplantation. We are excited by this unique opportunity to address one of society’s most challenging healthcare issues, with the potential to bring additional much-needed treatment options to patients,” said Vas Narasimhan, MD, CEO of Novartis.

IgAN is a progressive condition and as many as three in ten patients progress to kidney failure and dialysis within 10 years. In the U.S., it affects up to 21 people per million per year, with higher incidence in Asian populations. It is the most common cause of kidney failure in Caucasian young adults.

With increasing damage to the kidneys, proteinuria (protein in the urine) and hematuria (blood in the urine) can occur. IgAN patients with higher levels of protein in their urine ( ≥1 g/day) are at higher risk of disease progression. Availability of new treatments targeting different disease pathways are thus critical for these patients.

Chinooks’s atrasentan, an oral endothelin A receptor antagonist (ERA), is currently in Phase III development for IgAN with pivotal readout expected in Q4 2023. The drug has shown significant reductions in proteinuria and is also in early-stage development for other rare kidney diseases. Atrasentan has demonstrated a significant reduction in proteinuria versus baseline in a Phase II study, with good tolerability, including liver safety profile.

Zigakibart (BION-1301) is a subcutaneously administered anti-APRIL monoclonal antibody; with the potential to address the root cause of IgAN—the production of abnormal galactose-deficient IgA—and thus preserve kidney function. Interim Phase I/II data showed an impressive reduction in proteinuria versus baseline. As a targeted therapy, zigakibart is expected to have a better tolerability profile than broader-acting lymphocyte-depleting therapies. A Phase III trial of Zigakibart in IgAN is expected to start in Q3 2023.

Chinook specializes in modeling kidney disease and its pipeline addresses a number of severe renal conditions. The company says, “We seek to build our pipeline by leveraging insights in single cell RNA sequencing of patient kidney samples, human-derived organoids and new translational models in order to discover and develop therapeutics with mechanisms of action targeted against key kidney disease pathways.”

Also of Interest