HI-Bio Announces Positive Phase 2 IGNAZ Study Results for Felzartamab in IgA Nephropathy at ERA Congress

Human Immunology Biosciences (HI-Bio™), a clinical-stage biotechnology firm focusing on therapies for severe immune-mediated diseases, has announced promising interim results from its Phase 2 IGNAZ study. This study investigates the efficacy of the CD38 antibody felzartamab in treating IgA nephropathy (IgAN).

A notable outcome for patients receiving a nine-dose regimen over five months was a significant and sustained reduction in proteinuria, achieving approximately a 50% mean reduction in urinary protein-to-creatinine ratio (UPCR) at month 24, which is more than 18 months after the final dose. The patients also demonstrated stabilization in kidney function, as indicated by stable estimated glomerular filtration rate (eGFR) over 24 months. Felzartamab administration was generally well tolerated, with a safety profile aligning with previous studies.

Dr. Jürgen Floege, a study investigator and lead author from RWTH Aachen University in Germany, expressed optimism about the results. He noted that the durable reduction in proteinuria and stabilization of eGFR could be clinically significant for IgAN patients, suggesting felzartamab's potential in preserving kidney function without the necessity for chronic immunosuppression. Additionally, selective and durable reductions in IgA antibody levels were observed, with the recovery of IgG and IgM levels shortly after the last dose, indicating a favorable safety profile and sustained treatment benefit.

Dr. Uptal Patel, Chief Medical Officer at HI-Bio, highlighted that these findings are encouraging and represent the first data exploring felzartamab's application in IgAN treatment. Felzartamab's capability to selectively deplete CD38+ plasma cells could offer a disease-modifying approach, potentially preserving kidney function. Final data from the IGNAZ study is anticipated later this year, with plans to present the findings in a peer-reviewed forum and evaluate further development steps for felzartamab in this indication.

In the nine-dose group, patients experienced a prolonged pharmacodynamic effect, with IgA reductions sustained for over 18 months post-treatment, while IgG and IgM levels recovered. Felzartamab was generally well tolerated, with no dose-dependent adverse events or exposure-safety relationships. Most adverse events were mild, with infusion-related reactions (IRRs) being the most common. Two serious adverse events (an IRR and tendon rupture) occurred in felzartamab-treated patients, and infections were generally mild and balanced across treatment groups. Five patients discontinued treatment due to IRRs or hypersensitivity, primarily related to deviations from protocol-specified infusion rates or pre-medication errors.

The Phase 2 IGNAZ study is a randomized, placebo-controlled, multi-center trial designed to evaluate felzartamab's safety and efficacy in adults with high-risk IgAN. Patients were enrolled based on criteria including proteinuria (UPCR of at least 1.0 g/d) and eGFR (at least 30 ml/min/1.73 m2). Participants were randomized into four groups, receiving either placebo or varying doses of felzartamab over a 24-week treatment phase, including an open-label arm in Japan. The study enrolled 54 patients, with data analyzed per protocol.

These interim results were presented at the 61st European Renal Association (ERA) Congress in Stockholm, with the full presentation to be available on HI-Bio's website.

IgA Nephropathy Overview

IgA nephropathy (IgAN) is the most prevalent primary glomerulonephritis globally and a leading cause of chronic kidney disease. Up to 40% of IgAN patients progress to end-stage kidney disease about 20 years post-diagnosis. IgAN accounts for varying percentages of native-kidney biopsies worldwide, with significant incidences in Japan, Europe, and the United States.

About Felzartamab

Felzartamab is an investigational human monoclonal antibody targeting CD38, a protein on mature plasma cells. It has shown promise in clinical studies for selectively depleting CD38+ plasma cells, potentially improving outcomes in diseases driven by pathogenic antibodies. Initially developed by MorphoSys AG for multiple myeloma, HI-Bio now holds exclusive rights to develop and commercialize felzartamab globally, except for China and its territories.

About HI-Bio

HI-Bio focuses on developing precision therapies for immune-mediated diseases. The company aims to advance clinical immunology by targeting and depleting immune cell types driving these diseases. Their lead candidate, felzartamab, has shown potential in a range of indications, including antibody-mediated rejection, IgA nephropathy, lupus nephritis, and primary membranous nephropathy.

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