Chinook Therapeutics has enrolled the first subject in a Phase III clinical trial of anti-APRIL monoclonal antibody, zigakibart (BION-1301), in IgA nephropathy (IgAN) patients.
Known as the BEYOND study, the double-blind, multicentre, international, randomised, placebo-controlled trial will assess the efficacy and safety of zigakibart compared to a placebo in IgAN patients who are at risk of gradual kidney function loss.
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It intends to enrol nearly 272 subjects, who will be categorised to receive 600mg subcutaneous doses of zigakibart or a placebo, every two weeks for a total of 104 weeks.
The impact of zigakibart compared to a placebo on proteinuria from baseline to 40 weeks will be the trial’s primary efficacy endpoint.
Tolerability, safety, immunogenicity, pharmacokinetics, variation in estimated glomerular filtration rate (eGFR) at week 104 from baseline, and kidney transplantation or all-cause mortality will comprise some of the secondary and exploratory objectives.
Chinook Therapeutics president and CEO Eric Dobmeier said: “Initiation of the Phase III BEYOND study is an important step towards our goal of providing an innovative treatment option for patients with IgAN, a disease with high unmet need and limited treatment options.
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By GlobalData“The data from our ongoing Phase I/II trial of zigakibart supports our belief that binding and neutralising APRIL in patients with IgAN plays a key role in depleting pathogenic galactose deficient-IgA1, reducing proteinuria, and preserving kidney function for IgAN patients.”
In June 2023, the company reported data from a Phase I trial of CHK-336 for primary hyperoxaluria and other kidney stone ailments.
