Pharma Focus America

Chinook Therapeutics Initiates Pivotal Phase 3 BEYOND Trial of Zigakibart (BION-1301) for IgA Nephropathy Patients

Saturday, July 29, 2023

Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company specializing in precision medicines for kidney diseases, has announced the enrollment of the first patient with IgA nephropathy (IgAN) in the BEYOND study. This study is a pivotal phase 3 clinical trial evaluating the safety and efficacy of zigakibart (BION-1301), a potentially disease-modifying anti-APRIL monoclonal antibody.

According to Eric Dobmeier, the president, and chief executive officer of Chinook Therapeutics, the initiation of the phase 3 BEYOND study represents an important milestone towards their goal of providing an innovative treatment option for IgAN patients. This disease has high unmet needs and limited treatment options. The phase 1/2 trial data of zigakibart supports the belief that it plays a crucial role in reducing proteinuria, preserving kidney function, and depleting pathogenic galactose deficient-IgA1 in IgAN patients.

Vlado Perkovic, MBBS, PhD, FASN, FRACP, dean of medicine and health and Scientia professor at the University of New South Wales and co-chair of the BEYOND study steering committee, expressed satisfaction with the enrollment of the first patient and looks forward to continued enrollment in the phase 3 study. He believes that zigakibart could become an important new therapeutic treatment option for patients with IgAN, especially considering the disease's limited treatment choices and potential disease-modifying capabilities based on the encouraging results from the phase 1/2 study.

The BEYOND study is a global, randomized, multicenter, double-blind, placebo-controlled phase 3 clinical trial. It will involve approximately 272 patients with biopsy-proven IgAN and eGFR ≥ 30 mL/min/1.73m2. The participants will be randomized to receive either 600 mg of zigakibart or a matched placebo subcutaneously every two weeks for 104 weeks. Additionally, there will be an exploratory cohort of around 20 subjects with biopsy-confirmed IgAN and eGFR of ≥ 20 to < 30 mL/min/1.73 m2, which will not be included in the primary analysis.

The primary efficacy endpoint of the BEYOND study is to assess the effect of zigakibart versus placebo on proteinuria, measured by the change in urine protein to creatinine ratio (UPCR) from baseline to 40 weeks. Secondary and exploratory objectives include evaluating the change in eGFR from baseline to week 104, composite clinical outcomes related to eGFR reduction, safety and tolerability, the impact of zigakibart on disease biomarkers and health-related quality of life, as well as analyzing zigakibart pharmacokinetics and immunogenicity.

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