ProKidney Reports Positive Interim Results From Phase 2 REGEN-007 Study Of Rilparencel

(RTTNews) - ProKidney Corp. (PROK) Monday announced positive interim results from the Phase 2 REGEN-007 study of rilparencel, the company's renal autologous cell therapy, in patients with chronic kidney disease (CKD) caused by diabetes.

In the phase 2 REGEN-007 study, patients were randomized in two groups to receive two different dosing regimens. In group 1, patients received two rilparencel injections - one in each kidney, three months apart. Patients with at least 12 months follow-up after the second injection of rilparencel showed stabilized kidney function for 18 months.

Further, no rilparencel-related serious adverse events were observed.

Currently, the company's Phase 3 studies of rilparencel dubbed PROACT 1 and PROACT 2 have been resumed.

ProKidney also said that it has begun manufacturing for U.S. and non-European clinical study sites effective June 1. The company expects QP Declaration of Equivalence to EU GMPs to be received by the end of June 2024.