Biogen Inc. (BIIB) has shared promising findings from its Phase 2 IGNAZ study regarding the investigational anti-CD38 monoclonal antibody, felzartamab, for individuals with IgA nephropathy (IgAN). The study results showed significant decreases in proteinuria, stabilization of kidney function, and a prolonged therapeutic effect extending over 18 months post-administration of the final felzartamab dose.
The Phase 2 IGNAZ study involved 54 participants and examined both the efficacy and safety of felzartamab in patients at high risk of progressive kidney dysfunction due to IgAN. The data revealed that those undergoing a nine-dose regimen over six months experienced notable reductions in proteinuria levels, as measured by the urinary protein:creatinine ratio (UPCR), and maintained stable kidney function, as indicated by the estimated glomerular filtration rate (eGFR), through a 24-month period. Importantly, there was an average reduction of approximately 50% in UPCR at the 24-month mark, surpassing 18 months after the final dose.
These findings suggest that felzartamab holds potential for kidney function preservation through treatment cycles rather than continuous dosing. Further analysis indicated that felzartamab led to selective and sustained reductions in IgA antibody levels, with IgG and IgM levels returning to baseline three months after treatment cessation. This selectivity could maintain vital immune functions for infection protection. Overall, the treatment was well tolerated, aligning with safety profiles observed in earlier studies.
