WINSTON-SALEM, N.C. — November 6, 2025 — Leads & Copy — ProKidney Corp. (Nasdaq: PROK) presented full results from its Phase 2 REGEN-007 trial, which evaluated rilparencel in patients with advanced chronic kidney disease (CKD) and diabetes, at the American Society of Nephrology (ASN) Kidney Week 2025.
The data demonstrated that treatment with rilparencel resulted in statistically significant and clinically meaningful slowing of CKD progression in patients with advanced CKD and diabetes. The FDA previously confirmed that the estimated glomerular filtration rate (eGFR) slope is an acceptable surrogate endpoint for accelerated approval of rilparencel.
In Group 1 (n=24) patients, bilateral kidney injection with rilparencel resulted in a 4.6 mL/min/1.73m2 (78%) improvement in the annual decline of eGFR slope. No rilparencel-related serious adverse events were observed, and the overall study safety profile was consistent with previously reported study results and comparable to a kidney biopsy.
More than half of the patients required for the Phase 3 REGEN-006 (PROACT 1) accelerated approval analysis using eGFR slope have been enrolled, and topline results are anticipated in Q2 2027. Rilparencel is the only cell therapy in a Phase 3 clinical study for treating CKD and type 2 diabetes.
According to Dr. Arnold Silva, principal investigator of the REGEN-007 study, these latest study findings further confirm the potential of rilparencel to positively impact kidney function in patients with advanced CKD and diabetes. He noted that evidence of kidney function stabilization through assessments of eGFR slope, a valuable and clinically meaningful outcome measure of CKD progression, along with confirmation of a well-tolerated safety profile, support continued evaluation of rilparencel as a novel therapeutic option.
The Phase 2 REGEN-007 trial was a multi-center, open-label, 1:1 randomized two-arm trial in patients with advanced CKD and diabetes. Eligible participants were assigned to one of two treatment groups using different dosing regimens. Group 1 replicated the dosing schedule of the ongoing Phase 3 PROACT 1 study, in which patients receive two scheduled rilparencel injections (one in each kidney), approximately three months apart. Group 2 tested an exploratory dosing regimen to investigate whether disease progression triggers, rather than a time-based trigger, could optimize multiple doses of rilparencel. Participants were followed up to 18 months after their last injection.
Among Group 1 patients, 15 of 24 (63%) met key Phase 3 PROACT 1 inclusion criteria; in this subgroup, bilateral kidney injection resulted in a 5.5 mL/min/1.73m2 improvement in the annual decline in eGFR slope, or an 85% improvement that was statistically significant and clinically meaningful (p=0.005).
Bruce Culleton, M.D., Chief Executive Officer of ProKidney, said the full results from REGEN-007 reinforce the potential of rilparencel to address a significant unmet therapeutic need and make a meaningful difference in the lives of people living with CKD and their families.
Ethan Holdaway
Ethan.Holdaway@prokidney.com
Source: ProKidney Corp.
