FDA Gives Ruxoprubart Go-Ahead for Phase 2 Trial

The US Food and Drug Administration (FDA) has granted approval for the investigational drug ruxoprubart to begin phase 2 trials to test its efficacy in patients with ANCA-associated vasculitis (AAV). The current standard of care for AAV includes high doses of glucocorticoids plus ongoing administration of other immunosuppressive drugs, which have serious side effects.

Ruxoprubart is a high-affinity, humanized monoclonal antibody to Bb that selectively blocks the alternative pathway without affecting the classical pathway, which is critical for immunity. This gives ruxoprubart an advantage over existing FDA-approved complement blockers. The drug holds promise for several other renal disorders, including atypical hemolytic uremic syndrome and IgA nephropathy.

An upcoming study of 12 patients with AAV will evaluate ruxoprubart versus standard of care, as a previous study of the drug avacopan (TAVNEOS) did. Ruxoprubart may have an advantage over avacopan, which targets the toxin C5a, while ruxoprubart targets both C5a and C3a.

“We are thrilled to have gained FDA approval to address AAV in patients with an inadequate response to standard of care,” said Rekha Bansal, PhD, chief executive officer of NovelMed, the biopharmaceutical company that developed ruxoprubart. “Through this study, we aim to compare ruxoprubart with historical data on TAVNEOS, hoping to improve AAV patients’ lives substantially.”