ProKidney Corp. (NASDAQ:PROK) saw its stock skyrocket 115% following the release of positive topline results from its Phase 2 REGEN-007 clinical trial evaluating rilparencel in patients with chronic kidney disease (CKD) and diabetes.
The company, which focuses on late-stage cellular therapies, reported that patients in Group 1 of the trial experienced a dramatic 78% improvement in the rate of kidney function decline. Specifically, the estimated glomerular filtration rate (eGFR) slope improved from -5.8 mL/min/1.73m² before treatment to -1.3 mL/min/1.73m² after the final rilparencel injection. This 4.6 mL/min/1.73m² annual improvement was found to be statistically significant.
A second cohort, Group 2, which tested a different dosing schedule, showed a 50% improvement in eGFR slope. While promising, the difference in Group 2 was not statistically significant, but the company noted signs of a dose-response relationship.
The REGEN-007 study involved 49 participants, all of whom received at least one injection of rilparencel. Group 1 followed the same dosing strategy currently being used in the company’s Phase 3 PROACT 1 trial, which includes two rilparencel injections spaced about 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.
Importantly, the trial reported no serious adverse events linked to rilparencel. The safety data aligned with previous findings and was considered comparable to the risk profile of a kidney biopsy.
ProKidney plans to present the full data from REGEN-007 at the American Society of Nephrology’s 2025 Kidney Week as part of a late-breaking clinical trial session. The company also intends to meet with the FDA in a Type B meeting to discuss using eGFR slope as a surrogate endpoint to support accelerated approval for rilparencel.