ProKidney Receives Allowance from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for proact 1 (REGEN-006) and EMA Scientific Advice on Phase 3 Protocols of REACT for Diabetic Chronic Kidney Disease

WINSTON-SALEM, N.C., Nov. 03, 2022 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today 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).

“We are extremely pleased to announce that the MHRA has granted allowance to ProKidney to open sites in the UK, accepting the proact 1 study protocol that is already underway in the US and Canada. Our proact program of two pivotal phase 3 trials aims to proactively prevent the progression to renal failure,” said Dr. Tim Bertram, CEO, of ProKidney. “This next step fits well into the execution plans to recruit a total of 600 REACT-treated patients into this first of two global Phase 3 studies. We are actively working toward submitting clinical trial applications for REACT to reach new clinical research sites, providing options to physicians and their patients who are potentially in need of CKD treatment.”

Dr. Darin Weber, Senior Vice President of Regulatory Development, added “It is gratifying that we now have scientific advice from EMA that ProKidney’s overall registrational clinical development program, consisting of Phase 3 studies proact 1 and proact 2, if successful, can be the basis of an MAA to support commercialization in the European Union. The feedback from EMA is consistent with responses received from FDA following designation of REACT as a Regenerative Medicine Advanced Therapy (RMAT) product.”

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