ProKidney’s cell therapy shows promise in chronic kidney disease trial

ProKidney’s cell therapy rilparencel showed strong results in one phase 2 cohort, improving kidney function by 78%, while a second cohort failed to hit statistical significance.

Why it matters: The positive data supports the design of ProKidney’s ongoing phase 3 trial, potentially paving the way for accelerated FDA approval of a novel treatment for chronic kidney disease (CKD).

Backstory: Rilparencel is an autologous cell therapy that uses a patient’s kidney progenitor cells to regenerate function. The REGEN-007 trial tested two dosing regimens in diabetic CKD patients. Group 1 received two injections, Group 2 one (with a possible second). Only Group 1 saw statistically meaningful kidney improvement.

Big picture: With no serious side effects reported and strong early-phase results in the higher-dose group, rilparencel could become a first-in-class therapy to slow CKD progression. This would offer hope to millions with limited treatment options.

What’s next: ProKidney will meet the FDA this summer to discuss the phase 3 trial design. The company stock surged 48% following the announcement.