FDA authorizes study for new kidney transplantation drug

LEIDEN, Netherlands--Biotech company, Pharming Group NV  said Sept. 3 that the U.S. Food and Drug Administration has authorized a clinical study with recombinant human C1 inhibitor (rhC1INH) for the treatment of antibody-mediated rejection (AMR) in kidney transplantation.

Recombinant human C1 inhibitor is a key inhibitor of the classical complement system. In the planned study, rhC1INH will be evaluated in patients with AMR for its ability to prevent the inflammatory damage seen in the kidney, improve organ function, and reduce the likelihood of graft loss.

In this study, patients with AMR will examined to compare rhC1INH against standard of care, which consists of a combination of non-specific treatments including plasmapheresis, steroids and intravenous immunoglobulin.

Study researcher Dr. Hans Sollinger, University of Wisconsin said, “I am enthusiastic about taking rhC1INH forward in this clinical trial for antibody-mediated rejection. Antibody-mediated rejection is a serious and costly complication for which there is no specific therapy. RhC1INH has great potential in changing the way we treat AMR and extend the life of a transplanted kidney.”