ProKidney reports ‘positive’ interim data from RMCL-002 Phase 2 trial

ProKidney 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 renal autologous cell therapy. 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. Pablo Legorreta, Chairman of ProKidney’s Board of Directors, said “We are excited to report more mature interim data for ProKidney’s RMCL-002 Phase 2 study which suggests that REACT(R) was able to preserve kidney function for up to 30 months in a meaningful proportion of the patients treated in the study. When I got involved with ProKidney, I hoped that if REACT could slow the decline of kidney function in a meaningful proportion of patients, it could become an important and differentiated therapy. It is exciting to see that REACT appears to have exceeded my expectations of preservation of kidney function in this population that faces significant unmet medical needs.”