ProKidney Reports Positive Phase 2 REGEN-007 Trial Topline Results

July 8, 2025

DENVER, Colo., Jul 08, 2025 (247marketnews.com)- ProKidney (NASDAQ:PROK) reported positive topline results from the Group 1 modified intent-to-treat (mITT) population of its Phase 2 REGEN-007 trial, which evaluated rilparencel in patients with CKD and diabetes. The data demonstrated both statistical significance and clinical relevance in kidney function preservation.

Rilparencel, an autologous cellular therapy granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA, is currently being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) trial. The newly reported results further support the therapy’s potential to stabilize or slow the decline of kidney function in patients with advanced CKD and type 2 diabetes.

“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. These data bolster our confidence in the design of our ongoing Phase 3 PROACT 1 study given the similarity between the dosing regimen in REGEN-007 Group 1 and PROACT 1. It is also worth noting that 15 of the 24 patients in Group 1 (63%) met key Phase 3 PROACT 1 inclusion criteria, and similar efficacy results were observed in this subgroup compared to the full Group 1 results. We plan to submit the full results from REGEN-007 to ASN’s 2025 Kidney Week as a late-breaking clinical trial and are excited to share more details at that time with investors and the medical community,” said Bruce Culleton, M.D., CEO of ProKidney. “We also look forward to our upcoming FDA Type B meeting in the coming weeks to confirm our approach to eGFR slope as a surrogate endpoint for accelerated approval. This meeting represents an important step toward our goal of expediting rilparencel’s potential path to market in the U.S. where there remains a significant unmet clinical need in patients with advanced CKD and diabetes.”

Phase 2 REGEN-007 Trial Overview

REGEN-007 is a multi-center, open-label, randomized Phase 2 study in patients with diabetes and CKD, with baseline eGFR between 20–50 mL/min/1.73m². Fifty-three patients were randomized, and 49 received at least one rilparencel injection (mITT population). The trial compared two distinct dosing strategies:

  • Group 1 (n=24): Patients received two rilparencel injections (one in each kidney) approximately three months apart. This dosing regimen mirrors the ongoing Phase 3 PROACT 1 protocol.
  • Group 2 (n=25): Patients received one injection, with a potential second injection triggered by predefined markers of disease progression (≥20% eGFR decline or ≥30% increase in UACR).

The primary endpoint was the change in annualized eGFR slope from the pre-injection period to the post-treatment period, measured using a linear mixed effects model. Median follow-up after the final injection was approximately 18 months.

Key Topline Results

  • Group 1:
    • eGFR slope improved from -5.8 to -1.3 mL/min/1.73m² per year
    • Represents a 78% reduction in decline
    • The 4.6 mL/min/1.73m² per year difference was statistically significant (p < 0.001)
    • 63% (15 of 24) met key Phase 3 PROACT 1 inclusion criteria, with similar efficacy outcomes in this subgroup
  • Group 2:
    • eGFR slope improved from -3.4 to -1.7 mL/min/1.73m² per year
    • A 50% improvement; difference was not statistically significant (p = 0.085)
    • 60% (15 of 25) met dosing criteria for a second injection; median time to second dose: ~11 months

Safety Profile

Rilparencel was well tolerated, with no serious adverse events attributed to the therapy. The safety profile was consistent with previous studies and comparable to that of a standard kidney biopsy.

Next Steps & Regulatory Outlook

ProKidney intends to present the full results from REGEN-007 as a late-breaking clinical trial at ASN Kidney Week 2025. The Company also anticipates an upcoming FDA Type B meeting to discuss the use of eGFR slope as a surrogate endpoint for accelerated approval. This follows an earlier FDA Type B meeting in late 2024, during which the agency confirmed rilparencel’s eligibility for this regulatory pathway.

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