Chinook Therapeutics Presents BION-1301 Interim Phase 1/2 Data in Patients with IgA Nephropathy (IgAN) at the 58th ERA-EDTA Virtual Congress
SEATTLE, June 08, 2021 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced the presentation of data from the ongoing phase 1/2 study of BION-1301 in patients with IgAN. The findings were presented in an oral presentation at the 58th European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress.
“We are encouraged by the data we have generated to date for BION-1301 in patients with IgAN, including the clinically meaningful reductions in proteinuria observed, as well as safety, tolerability, PK and mechanistic biomarker responses,” said Alan Glicklich, M.D., chief medical officer of Chinook Therapeutics. “The data generated thus far have reaffirmed our belief that blocking and neutralizing APRIL in patients with IgAN plays a key role in depleting pathogenic Gd-IgA1 and reducing proteinuria, demonstrating strong rationale for BION-1301’s disease-modifying mechanism of action in IgAN.”
FC 040: Interim Results of Phase 1 and 2 Trials to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of BION-1301 in Patients with IgA Nephropathy
BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 1/2 clinical development for IgAN. Blocking APRIL is a potential disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1) to prevent the formation of immune complexes that deposit in the glomeruli of the kidney, causing injury.
Part 3 of the ongoing phase 1/2 multi-center trial (see www.clinicaltrials.gov, identifier NCT03945318) is evaluating the safety, tolerability, PK and pharmacodynamics (PD) of BION-1301 in patients with IgAN in an open-label setting. Patients in Cohort 1 receive an intravenous (IV) dose of 450 mg of BION-1301 every two weeks for up to 52 weeks. Patients in subsequent cohorts in Part 3 will be dosed subcutaneously.
Key highlights from the oral presentation include the following:
Cohort 2 in Part 3 of the ongoing phase 1/2 study will soon begin enrolling patients with IgAN utilizing subcutaneous administration of BION-1301. To help inform future patient selection for clinical studies of BION-1301, biomarker analysis from IgAN patient serum in the NURTuRE CKD patient biobank is also ongoing, integrating patient characteristics, disease progression, kidney histopathology as well as transcriptomics and proteomic analysis.
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Conference Call and Webcast Details
To access the live webcast, subsequent archived recording and slides that were developed to complement this and other company presentations, please visit the Investors section of Chinook’s website. The archived webcast will remain available for replay on Chinook’s website for 90 days.
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