ProKidney Corp. (PROK) has announced encouraging interim results from its Phase 2 REGEN-007 study concerning rilparencel, the company’s innovative renal autologous cell therapy, aimed at treating patients with chronic kidney disease (CKD) induced by diabetes.
In the study, participants were divided into two groups to receive various dosing regimens. The first group received two rilparencel injections, one in each kidney, spaced three months apart. Notably, those with at least 12 months of follow-up after the second injection demonstrated stabilized kidney function over an 18-month period. Importantly, no serious adverse events related to rilparencel were reported.
Furthermore, ProKidney has resumed its Phase 3 studies of rilparencel, known as PROACT 1 and PROACT 2. As part of their ongoing expansion, the company has also initiated manufacturing for clinical study sites in the U.S. and outside Europe as of June 1. They anticipate receiving the Qualified Person (QP) Declaration of Equivalence to EU Good Manufacturing Practices (GMPs) by the end of June 2024.
