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Investing.com -- ProKidney Corp. (NASDAQ:PROK) stock surged 115% after the company reported statistically significant and clinically meaningful positive topline results from its Phase 2 REGEN-007 trial evaluating rilparencel in patients with chronic kidney disease (CKD) and diabetes.
The late clinical-stage cellular therapeutics company announced that patients in Group 1 of the trial showed a 78% improvement in annual kidney function decline following treatment. The annual decline in estimated glomerular filtration rate (eGFR) slope improved from -5.8 mL/min/1.73m² in the pre-injection period to -1.3 mL/min/1.73m² after the last rilparencel injection, representing a statistically significant difference of 4.6 mL/min/1.73m² per year.
Group 2, which tested an exploratory dosing regimen, showed a 50% improvement in kidney function decline, suggesting evidence of a dose response, though this difference was not statistically significant.
The REGEN-007 trial evaluated 49 patients who received at least one rilparencel injection across two treatment groups. Group 1 replicated the dosing schedule of the company’s ongoing Phase 3 PROACT 1 study, with patients receiving two scheduled injections approximately three months apart.
"We are very encouraged by the REGEN-007 topline results that demonstrated a robust improvement in eGFR slope following treatment with rilparencel in Group 1 as well as evidence of a dose response in Group 2," said Bruce Culleton, M.D., CEO of ProKidney.
No rilparencel-related serious adverse events were observed in the study, with the safety profile consistent with previously reported results and comparable to a kidney biopsy.
The company plans to submit the full results from REGEN-007 to the American Society of Nephrology’s 2025 Kidney Week as a late-breaking clinical trial. ProKidney is also preparing for an upcoming FDA Type B meeting to confirm its approach to eGFR slope as a surrogate endpoint for accelerated approval.
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