Eledon Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to evaluate tegoprubart for the treatment of IgA Nephropathy (IgAN). Eledon plans to open U.S. sites under this IND as part of its ongoing global Phase 2a clinical trial evaluating tegoprubart for the treatment of IgAN. Including the U.S., the trial has now received regulatory clearances in 10 countries with plans to expand the study in up to 2 additional countries, including China.

Multiple patients in the Phase 2a study have begun receiving treatment with tegoprubart. The global multicenter, open-label study is enrolling up to 21 patients in each of two dose cohorts with confirmed diagnosis of IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening. The study will evaluate the safety and efficacy of tegoprubart, with the primary endpoint being change from baseline in urine protein (assessed as urine protein to creatinine ratio) after 24 weeks of therapy.

Dosing will continue through 96 weeks, and change from baseline in eGFR slope will be assessed at 96 weeks. Preclinical evidence has demonstrated that blocking CD40L signaling can improve proteinuria, reduce autoantibodies, decrease immune cell infiltration into the kidneys, and improve survival.