Breakthrough in Kidney Disease Treatment Unveiled at European Renal Association Congress

Breakthrough in Kidney Disease Treatment Unveiled at European Renal Association Congress

Katarzyna Nowak
2 min read

Breakthrough in Kidney Disease Treatment Unveiled at European Renal Association Congress

At the recent European Renal Association Congress, groundbreaking interim results were divulged by Human Immunology Bioscience from their Phase II IGNAZ clinical trial, showcasing the remarkable efficacy of MOR-202 (felzartamab) in substantially reducing proteinuria in patients with immunoglobulin A nephropathy (IgAN). The ongoing and double-blind study exhibited a compelling up to 50% reduction in the urine protein creatinine ratio following a nine-dose regimen over 24 months. Notably, key opinion leaders from GlobalData emphasized the imperative requirement for advanced therapies in kidney disease, emphasizing the potential high value of felzartamab's mechanism for nephrologists. Moreover, the drug, targeting CD38, has been well-perceived and recently garnered Orphan Drug Designation from the FDA. As Biogen prepares to acquire Human Immunology Biosciences for $1.8 billion, this strategic move has the potential to fortify the development and commercialization of felzartamab, ultimately benefiting IgAN patients tremendously.

Key Takeaways

  • Positive Interim Results: The Phase II IGNAZ trial exhibited profound and enduring reduction in proteinuria with MOR-202 (felzartamab) in IgAN patients.
  • Clinical Value High: GlobalData highlights the study's potential high clinical value for nephrologists seeking optimal IgAN treatments.
  • Well-Tolerated Treatment: Felzartamab demonstrated good tolerability in high-risk IgAN participants.
  • Orphan Drug Designation: In March 2024, felzartamab received Orphan Drug Designation from the FDA for antibody-mediated rejection in kidney transplant recipients.
  • Biogen Acquisition: Biogen's acquisition of Human Immunology Biosciences for $1.8bn could bolster Biogen's late-stage pipeline and accelerate felzartamab's development.


The encouraging interim results of MOR-202 (felzartamab) in treating IgAN, highlighted at the European Renal Association Congress, signify a momentous stride in kidney disease therapies. This advancement presents the potential to alleviate patients' conditions by reducing proteinuria and enhancing treatment alternatives. Biogen's acquisition of Human Immunology Biosciences for $1.8 billion is a strategic maneuver that could expedite the drug's market entry and augment Biogen's portfolio. The FDA's Orphan Drug Designation underscores the drug's potential in niche markets, ultimately reshaping treatment standards in nephrology and positively influencing healthcare costs and patient outcomes in the long run.

Did You Know?

  • Immunoglobulin A Nephropathy (IgAN): A prevalent kidney disease characterized by the accumulation of immunoglobulin A in the glomeruli, resulting in inflammation and damage that can impair kidney function.
  • Proteinuria: The presence of an unusual amount of protein in the urine, indicating kidney damage, typically occurring when the kidneys' filters are damaged, allowing protein to leak from the blood into the urine.
  • Orphan Drug Designation: A status granted by the FDA to drugs intended to address rare diseases or conditions affecting fewer than 200,000 people in the United States. This designation provides incentives such as tax credits for clinical research costs, FDA user-fee benefits, and potential market exclusivity for seven years if the drug is approved.

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