Human Immunology Biosciences (HI-Bio) has reported positive outcomes from the Phase II clinical trial of felzartamab, in treating late antibody-mediated rejection (AMR) in kidney transplant recipients.

The investigator-sponsored, double-blind, placebo-controlled study aimed to evaluate the safety and tolerability of felzartamab in adults who experienced late AMR at least six months post-kidney transplantation.

Participants were randomly assigned to receive either felzartamab or a placebo across nine infusions over 20 weeks, followed by a 32-week observation period.

The trial enrolled 22 patients, with felzartamab showing an acceptable safety profile and most adverse events being mild or moderate.

Notably, infusion reactions were more common during the first infusion among the felzartamab group without any treatment-linked discontinuations reported.

On key secondary endpoints, felzartamab showed potential in resolving AMR according to the Banff Classification.

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At week 24, 82% of patients in the treatment arm saw a resolution of AMR, compared to 20% in the placebo group.

Additionally, one patient on placebo experienced graft loss due to persistent, chronic active AMR.

The median microvascular inflammation score was lower in the felzartamab group at week 24, with 64% achieving a score of zero.

Furthermore, 67% of those who saw resolution at 24 weeks maintained it at 52 weeks, without any drug administration during the observation period.

The treatment also led to a significant reduction in donor-derived cell-free DNA levels, an indicator of allograft injury.

HI-Bio chief medical officer Uptal Patel said: “We believe these data demonstrate the potential for felzartamab to help preserve the transformative and often life-saving benefit of a kidney transplant by resolving a leading cause of rejection.

“Based on the observed activity and concurrence of results across key biomarkers of graft damage and function, we continue to be confident in our anti-CD38 depletion strategy with felzartamab. We intend to advance felzartamab to late-stage studies in antibody-mediated rejection and other immune-mediated diseases, where patients have serious unmet needs.”

In April last year, the company reported positive data from two Phase ll trials, M-PLACE and NewPLACE, assessing felzartamab for the treatment of primary membranous nephropathy (PMN).