ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT) for Diabetic CKD and Provides Corporate Updates

Updated positive interim Phase 2 data demonstrate potential efficacy of REACT to preserve kidney function in moderate and high-risk diabetic CKD patients

Focusing Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure and need for renal replacement therapy

Dr. Bruce Culleton appointed ProKidney CEO following Dr. Tim Bertram’s transition to advisory role

Sufficient capital to fund operations into fourth quarter 2025

ProKidney to host conference call and webcast tomorrow at 8:00 a.m. ET

WINSTON-SALEM, N.C., Nov. 13, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced updated positive interim diabetic CKD data from its RMCL-002 Phase 2 study that support the Company’s evolution into late-stage development and position the Company to change the treatment paradigm in high-risk diabetic CKD patients with its REACT (rilparencel) renal autologous cell therapy.

Positive interim Phase 2 data demonstrate the potential of REACT to preserve kidney function in moderate and high-risk diabetic CKD patients. Updated interim REACT RMCL-002 study data support continued investigation of REACT’s potential to benefit patients with moderate and high-risk diabetic CKD. The updated data include information from 83 patients enrolled in the RMCL-002 study. All patients had Stage 3 or 4 CKD caused by type 2 diabetes. The ongoing Phase 2 clinical study assessed adverse events and changes in kidney function as measured by estimated glomerular filtration rate (eGFR), as primary study endpoints. The dataset revealed a safety profile in line with previous Phase 1 & 2 REACT trials, with REACT showing a safety profile similar to that of a kidney biopsy. Overall, the updated Phase 2 trial data showed preservation of kidney function in several patient groups with advanced CKD caused by type 2 diabetes, with the most notable potential benefit shown in patients who had the highest risk of kidney failure (CKD Stage 4 with severe albuminuria), where there remains a significant unmet clinical need.