Eledon Secures FDA Clearance For Kidney Transplant Rejection Study

The U.S. Food and Drug Administration (FDA) has cleared the Eledon Pharmaceuticals’ ELDN Investigational New Drug (IND) application to evaluate Tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

The IND-opening phase 2 study will evaluate safety, pharmacokinetic, and efficacy of Tegoprubart in approximately 120 participants (60/arm) undergoing kidney transplant.

The primary endpoint of the study will compare the mean estimated glomerular filtration rate (eGFR) at 12 months for Tegoprubart compared with the current standard of care.

The secondary objectives of the study include safety, incidence of new onset diabetes, and participant and graft survival.

David-Alexandre C. Gros, Chief Executive Officer, commented: "We believe strongly in tegoprubart's potential to supplant CNIs in the immunosuppressive regimen of kidney transplant patients, potentially leading to reduced side effects such as diabetes and hypertension, better kidney allograft function, and a resulting longer functional life of transplanted kidneys.”

Price Action : Eledon shares closed Friday's trading 1.35 percent higher at $3.01