ProKidney Presents Full Results from the Phase 2 REGEN-007 Trial of Rilparencel at the American Society of Nephrology Kidney Week 2025

Core Insights - ProKidney Corp. presented full results from the Phase 2 REGEN-007 trial, demonstrating the potential of rilparencel to preserve kidney function in patients with advanced chronic kidney disease (CKD) and diabetes [1][2][3] Phase 2 REGEN-007 Overview - The REGEN-007 trial was a multi-center, open-label, randomized study involving two treatment groups, focusing on different dosing regimens of rilparencel [4] - Group 1 followed the dosing schedule of the ongoing Phase 3 PROACT 1 study, while Group 2 tested an exploratory regimen based on disease progression triggers [4] - A total of 87 rilparencel injections were administered to 49 participants, with follow-ups extending up to 18 months post-injection [4] Efficacy and Safety Findings - Rilparencel treatment resulted in a statistically significant 4.6 mL/min/1.73m² (78%) improvement in the annual decline of estimated glomerular filtration rate (eGFR) slope in Group 1 [6][7] - Among Group 1 patients, 63% met key Phase 3 PROACT 1 inclusion criteria, with a 5.5 mL/min/1.73m² (85%) improvement observed in this subgroup [7] - Group 2 showed a 1.7 mL/min/1.73m² (50%) improvement in eGFR slope, although this was not statistically significant [8] - No serious adverse events related to rilparencel were reported, and the safety profile was consistent with previous studies [6][14] Phase 3 PROACT 1 Program Update - The Phase 3 PROACT 1 trial aims to further assess rilparencel's potential to preserve kidney function in patients with advanced CKD and type 2 diabetes [9] - The FDA confirmed that eGFR slope is an acceptable surrogate endpoint for the study, supporting both accelerated and confirmatory approval pathways for rilparencel [9] - More than half of the required 360 patients for the accelerated approval analysis had been enrolled as of August 2025, with topline results expected in Q2 2027 [9] About Chronic Kidney Disease - CKD is a progressive condition affecting approximately 37 million adults in the U.S., with diabetes being the leading cause [11] - ProKidney is targeting patients with Stage 3b/4 CKD and diabetes, a population estimated to include 1 to 2 million individuals in the U.S. [11] - There is a significant unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in advanced CKD patients [11] About ProKidney Corp. - ProKidney is a pioneer in cell therapy for CKD, with rilparencel being a first-in-class autologous cellular therapy currently in Phase 3 trials [12] - The company was founded in 2015 and has a decade of research backing its innovative treatment approach [12]