Human Immunology Biosciences, Inc. (HI-Bio) reported data from a pair of Phase II trials on 11 April that appear to position its anti-CD38 agent as a strong competitor in primary membranous nephropathy (PMN), where Roche Holding AG has its anti-CD20 cancer drug Gazyva in Phase III. HI-Bio’s felzartamab demonstrated dose-dependent reductions of pathogenic antibodies in the M-PLACE and NewPLACE studies, and the company will start talking to regulators about a pivotal trial in the rare kidney disease.
HI Bio Reaches For The Lead With Phase II Primary Membranous Nephropathy Data
While Roche is in Phase III with Gazyva, HI-Bio thinks its autoantibody-depleting mechanism may be the best approach in PMN.
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