Milestone: A novel antibody for chronic kidney disease is now entering clinical phase

May 11, 2021

Chronic kidney diseases are a severe and growing worldwide problem with a lack of effective treatments often leading to dialysis, transplantation, and high costs to health care systems. Now, a monoclonal antibody, named BION-1301 (anti-APRIL), is being developed to treat patients with IgA nephropathy.
BION-1301 is a potential disease-modifying approach to prevent the formation of immune complexes that deposit in the glomeruli of the kidney, causing damage. BION-1301 was developed in a TIP Pharma consortium by prof. Jan Paul Medema and dr. Hans van Eenennaam partly at the Amsterdam UMC and is now a pipeline product of Chinook Therapeutics, which recently reported that during the phase 1 trial, healthy volunteers well-tolerated BION-1301 with no serious adverse events, a pharmacokinetic half-life of approximately 33 days. The antibody demonstrated dose-dependent pharmacodynamic effects characterized by durable reductions in serum levels of free APRIL, IgA, galactose-deficient IgA (Gd-IgA1) and IgM, with a lesser reduction in IgG. Now, BION-1301 is evaluated in patients with IgA nephropathy in a phase 1b trial.

Chinook Therapeutics
Chinook is a clinical-stage biopharmaceutical company discovering, developing and commercializing precision medicines for rare, severe chronic kidney diseases.

World Congress of Nephrology 2021
The ongoing phase 1 multi-center trial was presented at World Congress of Nephrology 2021.
For more information see WCN21-0706: A Phase 1, Open Label, Randomized, Single Dose, Parallel Group Safety and Bioavailability Study of BION-1301 Administered by Intravenous (IV) and Subcutaneous (SC) Routes.