IGNAZ trial interim results, HI-Bio’s potential

To differentiate in IgAN space, says GlobalData

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IGNAZ
Representative image. iStock

At this year’s European Renal Association, positive results were presented from Human Immunology Bioscience’s (HI-Bio) interim results of the Phase II IGNAZ clinical trial. According to the results, the use of MOR-202 (felzartamab) demonstrated a deep and durable reduction in proteinuria in patients with immunoglobulin A (IgA) nephropathy (IgAN). The drug potentially fills an unmet need in the IgAN space as it has an alternate mechanism of action to currently marketed therapies, says GlobalData, a leading data and analytics company.

IGNAZ is an ongoing, randomized, double-blind, placebo-controlled, multicenter, Phase II a 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. Additionally, felzartamab was well tolerated in participants with high-risk IgAN.

Kajal Jaddoo, senior pharma analyst at GlobalData, said, “According to key opinion leaders (KOLs) interviewed by GlobalData, unmet needs in the kidney disease space include next-generation therapies with alternate mechanisms of action and enhanced clinical profiles. This study could be of high clinical value to nephrologists who are seeking an optimal treatment of choice for IgAN patients.”

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 FDA for antibody-mediated rejection in kidney transplant recipients.

He concludes, “It was recently announced that Biogen will be acquiring HI-Bio for $1.8 billion. This acquisition deal could be significant as it will help Biogen bolster its late-stage pipeline. In addition, Biogen’s strong commercialization capabilities may accelerate the development of felzartamab and help to better address the therapeutic needs of IgAN patients.”

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