ProKidney confirms Phase 3 program for autologous kidney cell therapy REACT®

Two Phase 3 controlled trials with substantially similar design to enroll 1,200 subjects with diabetic CKD

WINSTON-SALEM, N.C., April 12, 2022 (GLOBE NEWSWIRE) -- ProKidney LP (“ProKidney”), a leading clinical-stage cellular therapeutics company focused on therapies for chronic kidney disease (“CKD”), today announced the updated design for its REACT® Phase 3 program.

REGEN-006 and REGEN-016 are expected together to enroll up to 1,200 subjects with CKD on optimized standard of care in two Phase 3 trials. Each trial is expected to enroll approximately 600 subjects with CKD due to type 2 diabetes in multiple centers in the United States, Europe, Latin America, and Asia Pacific. The FDA has indicated that these trials may be sufficient to support regulatory filing of a Biologic License Application (BLA) for our transformational cell therapy for CKD if they meet the primary and key secondary endpoints.

Subjects will be randomized 1:1 into either a REACT® treatment arm and undergo a kidney biopsy or a sham control arm. The primary objective of each study is to assess the efficacy of up to two REACT® injections given three months apart and delivered into biopsied and non-biopsied contralateral kidneys using a minimally invasive percutaneous approach. The primary composite endpoint is the time from first injection to the earliest of:

• at least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days; or
• eGFR