Rilparencel injections improve kidney function in patients with chronic kidney disease.

Regen-007 trial results show that rilparencel injections stabilized kidney function and improved the annual decline in eGFR slope by 78% in Group 1 and 50% in Group 2. The findings are significant and clinically meaningful, with Group 1 experiencing a 4.6 mL/min/1.73m^2 per year difference. The results will be submitted to the American Society of Nephrology 2025 Kidney Week as a late-breaking clinical trial.

ProKidney Corp. (NASDAQ: PROK) has announced significant positive topline results from its Phase 2 REGEN-007 trial evaluating rilparencel for chronic kidney disease (CKD) and diabetes. The trial demonstrated a robust improvement in kidney function decline, with notable findings in both treatment groups.

In Group 1, which received two rilparencel injections, there was a 78% improvement in annual eGFR slope decline, from -5.8 to -1.3 mL/min/1.73m² (p0.001). This represents a clinically meaningful difference of 4.6 mL/min/1.73m² per year. Group 2, which tested a conditional second-dose approach, showed a 50% improvement in kidney function decline, although this improvement was not statistically significant (p=0.085).

The therapy demonstrated a favorable safety profile with no rilparencel-related serious adverse events reported. This is crucial for a therapy targeting chronic administration in a vulnerable population. Most promising for investors is that 63% of Group 1 patients met key inclusion criteria for the ongoing Phase 3 PROACT 1 trial and showed similar efficacy results, suggesting the positive findings may translate to the larger pivotal study.

The upcoming FDA Type B meeting to confirm eGFR slope as a surrogate endpoint for accelerated approval represents a potential regulatory catalyst that could expedite rilparencel's path to market. For patients with advanced CKD and diabetes, these results offer hope for a therapy that could significantly slow disease progression in a condition with limited treatment options beyond standard of care medications like ACEi/ARBs and SGLT2 inhibitors.

The full results from REGEN-007 will be submitted to the American Society of Nephrology (ASN) 2025 Kidney Week as a late-breaking clinical trial.

References:
[1] https://www.stocktitan.net/news/PROK/pro-kidney-reports-statistically-and-clinically-significant-topline-6tkpnaw99kjd.html