ProKidney updates on rilparencel’s registrational path to potential US approval

US clinical-stage biotech ProKidney (Nasdaq: PROK) announced strategic updates to its Phase III program for rilparencel, an investigational treatment to potentially preserve kidney function in patients with type 2 diabetes and advanced chronic kidney disease (CKD).

ProKidney recently completed a comprehensive internal and external review, including engaging with ex-Food and Drug Administration (FDA) officials and seasoned regulatory experts, to determine the optimal path to bring rilparencel to patients in the US with type 2 diabetes and advanced CKD – a market where there is high unmet clinical and economic need.

An important conclusion of this review is that under the provisions of the Regenerative Medicine Advanced Therapy (RMAT) designation, the company believes rilparencel is eligible for initial FDA approval under an expedited approval pathway based upon successful completion of the ongoing Phase III REGEN-006 (PROACT 1) trial. ProKidney believes that the Phase III REGEN-016 (PROACT 2) trial is not required for initial US registration.