Positive Phase II IGNAZ study results for HI-Bio’s felzartamab

Privately-held US Biotech Human Immunology Biosciences (HI-Bio) has announced positive interim results from the randomized, placebo-controlled Phase II IGNAZ study of the investigational CD38 antibody felzartamab in the treatment of IgA nephropathy (IgAN).

The news comes just days after HI-Bio accepted an up to $1.8 billion takeover bid from US pharma biotech major Biogen (Nasdaq: BIIB), for whom felzartamab was a main attraction.

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.