Human Immunology Biosciences (HI-Bio) has reported positive results from a Phase II clinical trial of felzaltamab in the treatment of late antibody-mediated rejection (AMR) in kidney transplant patients.
The investigator-initiated, double-blind, placebo-controlled study aimed to evaluate the safety and tolerability of felzalutamab in adults who experienced late AMR within at least 6 months after kidney transplantation.
Participants were randomly assigned to receive either felzalutamab or a placebo in nine infusions over 20 weeks, followed by a 32-week observation period.
The study enrolled 22 patients and showed that felzaltamab had a tolerable safety profile, with most adverse events being mild or moderate.
Of note, more infusion reactions were observed during the first infusion in the felzalutamab group, but no treatment-related discontinuations were reported.
In the key secondary endpoint, felzalutamab demonstrated the potential to resolve AMR according to the Banff classification.
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At week 24, 82% of patients in the treatment group experienced resolution of AMR compared with 20% in the placebo group.
Additionally, one patient receiving placebo experienced graft loss due to persistent chronic active AMR.
At week 24, the median microvascular inflammation score was lower in the felzaltamab group, with 64% achieving a score of 0.
Additionally, 67% of people whose symptoms improved at week 24 maintained their improvement at week 52 without needing medication during the follow-up period.
The treatment also significantly reduced levels of donor-derived free DNA, a marker of allograft damage.
“We believe these data suggest that felzalutamab has the potential to help preserve the groundbreaking and often life-saving benefits of kidney transplantation by addressing a major cause of rejection,” said Uptal Patel, chief medical officer at HI-Bio.
“Based on the activity observed and the concordance of results for key biomarkers of graft damage and function, we remain confident in our anti-CD38 depletion strategy with felzalutamab. We intend to advance felzalutamab into later-stage studies where patients have significant unmet need in antibody-mediated rejection and other immune-mediated diseases.”
Last April, the company reported positive data from two Phase II trials, M-PLACE and NewPLACE, evaluating felzalutamab for the treatment of primary membranous nephropathy (PMN).
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