ProKidney Corp., a late clinical-stage cellular therapeutics company, has announced statistically significant and clinically meaningful topline results from their Phase 2 REGEN-007 trial. This trial evaluated the autologous cellular therapy, rilparencel, in patients with chronic kidney disease (CKD) and diabetes. The results indicated a robust improvement in eGFR slope following treatment in Group 1, alongside evidence of a dose response in Group 2. The company plans to submit the full results for presentation at the American Society of Nephrology's 2025 Kidney Week as a late-breaking clinical trial. ProKidney is also preparing for a forthcoming FDA Type B meeting to confirm the use of eGFR slope as a surrogate endpoint for accelerated approval of rilparencel.
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