At this year’s European Renal Association Congress, positive interim results were presented from Human Immunology Bioscience’s Phase II IGNAZ clinical trial.
According to the interim results, the use of MOR-202 (felzartamab) demonstrated a deep and durable reduction in proteinuria in patients with immunoglobulin A nephropathy (IgAN).
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Key opinion leaders interviewed by leading data and analytics company GlobalData emphasised that unmet needs in the kidney disease space include next-generation therapies with alternate mechanisms of action and enhanced clinical profiles.
GlobalData believes that this study could be of high clinical value to nephrologists who are seeking an optimal treatment of choice for IgAN patients.
IGNAZ is an ongoing, randomised, double-blind, placebo-controlled, multicentre, Phase IIa study to assess the safety and efficacy of felzartamab.
The interim results showed that a nine-dose regimen of felzartamab demonstrated a deep and durable reduction in proteinuria, reaching up to an approximate 50% mean reduction in urine protein creatinine ratio at 24 months.
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By GlobalDataAdditionally, felzartamab was well-tolerated in participants with high-risk IgAN.
Felzartamab is a fully human monoclonal antibody directed against CD38, which is one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells.
In March 2024, felzartamab received Orphan Drug Designation from the US Food and Drug Administration for antibody-mediated rejection in kidney transplant recipients.
It was recently announced that Biogen will be acquiring Human Immunology Biosciences for $1.8bn.
This acquisition deal could be significant as it will help Biogen bolster its late-stage pipeline.
In addition, Biogen’s strong commercialisation capabilities may accelerate the development of felzartamab and help to better address the therapeutic needs of IgAN patients.
