New 100-week data from the current phase-1/2 study by Zigakibart, a monoclonal anti-acril antibody, underpin potential as a disease-modifying treatment for IGA Nephropathy (IGAN). The results presented today at the 62nd ERA Congress show a continued proteinuria remission, a stable kidney function and a soothing security profile.
Igan is the world’s most common form of glomerular disease and a common cause of chronic kidney diseases. The pathogenesis is characterized by inflammation and progressive kidney damage that can lead to kidney failure. Many patients do not know that they suffer from the disease until there have been considerable kidney damage, and 50 % of Igan patients ultimately develop kidney failure.
By reducing the April signal path and reducing the production of the pathogenic galactose debecause ofga1), Zigakibart starts one of the main drivers of the disease progression. “Zigakibart was developed to interrupt the triggering factor in Igan pathogenesis, and offers a new approach that can stop or delay the progression of the disease,” said the senior test doctor Professor Jonathan Barratt.
The ADU-CL-19 study included 40 adults with a bioptically confirmed Igan and persistent proteinuria despite stable supportive therapy. Every two weeks, the patients received cigacic beard as an intravenous infusion or subcutaneous injection, in addition to maximum compatible renin-angiotensin system inhibitors (RASI), unless they did not tolerate Rasi-which is evidenced by the standard treatment.
In week 100, the proteinuria had dropped by 60 % compared to the starting value. More than half of the patients (55 %) reach <500 mg/24 h, and 31 % achieved <300 mg/24 h, which indicates deeper remission. The estimated glomerular filtration rate (EGFR) remained stable in all subgroups. "The consistency of EGFR stabilization is particularly encouraging over 100 weeks, even over the various proteinuria response groups," said Prof. Barratt.
The treatment also led to a continued reduction in serum munoglobulins, including a 74%decline in IGA and pathogenic GD-IGA1, which corresponds to the inhibition of the April signal path.
Zigakibart was well tolerated. Most undesirable events were light or moderate, there were no treatment -related severe infections or dropouts. Infections were the most common sars; The study fell together with a high prevalence of Covid-19.
This is the longest duration of the EGFR stabilization, which was reported for an anti-April active ingredient in Igan. “These long -term results strengthen trust in cigacic beard as a potential cornerstone therapy for Igan,” said Prof. Barratt. “We are excited to see how the upcoming phase 3 studies will further define its role.”
In the global phase 3 study in Beyond, Zigakibart is now being examined in a wider population group, with primary protein end points being examined after 40 weeks and long-term kidney function after 104 weeks.
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