, /PRNewswire/ -- Human Immunology Biosciences (HI-BioTM), a clinical-stage biotechnology company developing targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced positive interim results from the randomized, placebo-controlled Phase 2 IGNAZ study of the investigational CD38 antibody felzartamab in the treatment of IgA nephropathy (IgAN). Patients receiving a nine-dose regimen over five months experienced a deep and durable decrease in proteinuria levels, reaching up to ~50% mean reduction in UPCR at month 24, which was more than 18 months after the last dose. In addition, patients exhibited stabilization of kidney function as measured by eGFR through 24 months.
Administration of felzartamab was generally well tolerated with a safety profile consistent with prior studies. "Demonstrating a treatment effect that persists for more than 18 months after last dose of felzartamab represents a potential departure from plasma- or B-cell-modulating agents that require chronic dosing," commented Study Investigator and lead author Jürgen Floege, M.D.
, RWTH Aachen University, . "The reduction in proteinuria and stabilization of eGFR we are seeing represent clinically meaningful outcomes for patients with IgA nephropathy. The results also suggest the potential for felzartamab in helping to preserve kidney function while avoiding the need for chronic immunosuppression.
In addition, we are seeing selective and durable reductions in IgA antibody levels.
