ProKidney Reports Statistically and Clinically Significant Topline Results for the Phase 2 REGEN-007 Trial Evaluating Rilparencel in Patients with Chronic Kidney Disease and Diabetes

Core Insights - ProKidney Corp. reported positive topline results from the Phase 2 REGEN-007 trial for rilparencel, a therapy for chronic kidney disease (CKD) and diabetes, showing significant improvement in kidney function [1][2][5] - The company plans to present full results at the ASN's 2025 Kidney Week and is preparing for an FDA Type B meeting to discuss the use of eGFR slope as a surrogate endpoint for accelerated approval [2][10] Phase 2 REGEN-007 Trial Overview - The REGEN-007 trial involved 53 patients with diabetes and CKD, randomized into two groups with different dosing regimens [3][5] - Group 1 received two rilparencel injections, while Group 2 received a single injection with a potential second dose based on kidney function decline [3][4] Efficacy Results - In Group 1, the annual decline in eGFR improved by 78%, from -5.8 mL/min/1.73m² to -1.3 mL/min/1.73m², a statistically significant difference (p<0.001) [5][7] - In Group 2, the annual decline improved by 50%, from -3.4 mL/min/1.73m² to -1.7 mL/min/1.73m², though this was not statistically significant (p=0.085) [8][9] Safety Profile - No serious adverse events related to rilparencel were reported, and the safety profile was consistent with previous studies [9] Regulatory Progress - The FDA has indicated that an acceptable surrogate endpoint, such as eGFR slope, could facilitate accelerated approval for rilparencel [10] - The upcoming FDA Type B meeting will further discuss this approach [10] Market Context - CKD affects an estimated 37 million adults in the U.S., with diabetes being the leading cause, highlighting a significant unmet clinical need for effective therapies [11] - ProKidney is targeting patients with Stage 3b/4 CKD and diabetes, a population of 1 to 2 million in the U.S. [11]