ProKidney Corp. announced the allowance of the proact 1 (REGEN-006) Phase 3 study protocol for its investigational candidate REACT® by the United Kingdom's (UK) MHRA. This follows submission of a clinical trial application for the proact 1 Phase 3 study protocol previously allowed by the Food & Drug Administration (FDA) in the United States (US), where recruitment is actively underway, and now allows ProKidney to begin patient recruitment at clinical trial sites in the UK.

In a related regulatory development, ProKidney also received favorable scientific advice from the European Medicines Agency (EMA) on the adequacy of its Phase 3 development program, consisting of proact 1 and proact 2, to support an eventual marketing authorization application (MAA). About the REACT™ Global proact Phase 3 Program: The global Phase 3 program for REACT® (REnal Autologous Cell Therapy) is comprised of two studies: proact 1 (REGEN-006), which is currently enrolling patients, and proact 2 (REGEN-016), which will begin enrolling patients in early 2023. The trial names utilize the term ‘proact' to represent ProKidney's proactive approach to preventing the progression to renal failure and precluding the need for hemodialysis or transplant.

The studies will be enrolling patients with diabetic CKD in the U.S. and rest of the world, including multiple centers anticipated in the United Kingdom, European Union, Latin America, and Asia Pacific regions. Each study aims to enroll 300 patients per arm (active or sham) resulting in a total of approximately 1,200 subjects. Targeted study subject demographics include Type 2 diabetic mellitus, CKD with eGFR 20-50 ml/min/1.73 m2, and UACR ranging from 300-5000 mg/g and who are not on renal dialysis.

Study participants in the treatment arm will undergo a kidney biopsy and then be injected with REACT in each kidney once, with a three-month interval between injections. Study subjects randomized to the standard of care arm of the study will receive sham biopsies and injections. Following REACT or sham injections, subjects in both arms will be followed clinically until they reach one of the three components of the primary composite endpoint, which is the time from the first injection to the earliest of: At least 40% reduction in estimated glomerular filtration rate (eGFR), which is a measure of how well the kidneys are working; or eGFR<15mL/min/1.73m² sustained for 30 days; or Chronic dialysis; or Renal transplant; or Death from renal or cardiovascular causes.

In addition to the primary endpoint, key secondary endpoints will be included to evaluate trends in proteinuria, Quality of Life, other kidney associated laboratory parameters. Interim data from the global REACT Registrational Program including proact 1 interim results in late 2024 and proact 2 interim results in late 2025.