, /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 results from a Phase 2 investigator-sponsored clinical trial of felzartamab for late antibody-mediated rejection (AMR) in kidney transplant recipients. Felzartamab is an investigational monoclonal antibody designed to specifically target and deplete CD38+ cells, which can include plasmablasts, plasma cells and natural killer (NK) cells, which are believed to drive AMR and other IMDs. This double-blind, placebo-controlled Phase 2 study was designed to assess the safety and tolerability of felzartamab in adults with late AMR occurring at least 180 days after kidney transplantation.
Patients were randomized 1:1 to receive nine infusions of felzartamab (16 mg/kg) or placebo over 20 weeks, followed by an observation period of 32 weeks. Biopsies were taken at baseline, 24 weeks and 52 weeks. The study enrolled 22 patients.
Felzartamab had acceptable safety and side-effect profiles in patients with late AMR. Most adverse events were mild or moderate in severity. Mild or moderate infusion reactions, typically on the first infusion, occurred in patients in the felzartamab group (n=8).
There were no treatment-related discontinuations. Key secondary endpoints demonstrated potential for felzartamab to be the first effective therapeutic for late AMR, resolving disease according to .
