ProKidney Corp., a company specializing in cell therapeutics for chronic kidney disease, has announced the positive topline results from its Phase 2 REGEN-007 study. The study demonstrated a 78% improvement in the eGFR slope in Group 1 after treatment with rilparencel. Full results from the REGEN-007 study are set to be submitted as a late-breaking clinical trial at the American Society of Nephrology 2025 Kidney Week. Additionally, the FDA has confirmed the use of the eGFR slope as a surrogate endpoint for accelerated approval of rilparencel in patients with type 2 diabetes and advanced chronic kidney disease. The ongoing Phase 3 PROACT 1 study will serve as both the accelerated approval and confirmatory study, with topline data expected in the second quarter of 2027. ProKidney continues to enroll patients for this study and aims to bring a novel treatment option to address the unmet clinical needs in this patient population.
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