Eledon Shares Climb After Securing FDA Nod For Mid-Stage Kidney Disease Study

Eledon Pharmaceuticals ELDN received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to evaluate tegoprubart for the treatment of IgA Nephropathy (IgAN).

The company plans to open clinical sites in the United States under this IND as part of its ongoing global Phase 2a clinical trial evaluating tegoprubart.

The Phase 2a study will evaluate the safety and efficacy of tegoprubart in patients with IgA Nephropathy (IgAN).

The will enrol 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 primary endpoint of the study is change from baseline in urine protein (assessed as urine protein to creatinine ratio) after 24 weeks of therapy.

IgAN is the most common primary glomerulonephritis disease, affects approximately 150 thousand Americans and is distinguished by gradual, progressive kidney function deterioration which can potentially lead to End-Stage Renal Disease (ESRD), dialysis, renal transplant, and death.

Price Action : Eledon shares traded around 7 percent higher at $3.95 on Tuesday after-hours session.