Prokidney Updates Phase 3 Program to Accelerate Rilparencel’s Registration

 ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”), a late clinical-stage biotech company focused on the development of a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced strategic updates to its Phase 3 program for rilparencel, an investigational treatment to potentially preserve kidney function in patients with type 2 diabetes and advanced CKD.

ProKidney recently completed a comprehensive internal and external review, including engaging with ex-FDA officials and seasoned regulatory experts, to determine the optimal path to bring rilparencel to patients in the U.S. with type 2 diabetes and advanced CKD – a market where there is high unmet clinical and economic need. An important conclusion of this review is that under the provisions of the Regenerative Medicine Advanced Therapy (RMAT) designation, the Company believes rilparencel is eligible for initial FDA approval under an expedited approval pathway based upon successful completion of the ongoing Phase 3 REGEN-006 (PROACT 1) trial. ProKidney believes that the Phase 3 REGEN-016 (PROACT 2) trial is not required for initial U.S. registration. Thus, the Company will discontinue PROACT 2, which was focused on enrollment outside the U.S. With the discontinuation of PROACT 2, ProKidney now expects current cash to support operating plans into Q1 2027. The Company estimates the revised Phase 3 program will deliver topline results by Q3 2027 and reduce expenses by approximately $150 to $175 million.

“We decided to prioritize PROACT 1 to accelerate potential U.S. registration and commercial launch. We are confident that this strategic shift in our Phase 3 program is the most expeditious and resource efficient approach to bring rilparencel to market in the U.S., our highest priority market,” said Bruce Culleton, M.D., Chief Executive Officer. “The recent positive REGEN-007 interim data update in June further supports the urgency to bring our innovation to patients with advanced CKD. We look forward to continuing our engagement with the FDA, under the RMAT designation, to bring rilparencel to market.”

Today’s update follows a transformational period for ProKidney over the past 10 months. In November 2023, Bruce Culleton, M.D., a nephrologist and seasoned leader of kidney care organizations, was appointed Chief Executive Officer. Under Dr. Culleton’s leadership, ProKidney has made significant progress, including the implementation of improved quality management systems to ensure compliance with global standards for commercial manufacturing and the Phase 3 program, the refinement and restart of the Phase 3 program with a renewed focus on patients with advanced CKD in the U.S., and the appointment of several key executive leaders across clinical operations, manufacturing, human resources, and business operations. The Company also released final data from the Phase 2 RMCL-002 trial and interim data from the Phase 2 REGEN-007 trial. Data from these trials suggest that rilparencel’s greatest potential therapeutic impact is in advanced CKD patients at high risk of kidney failure. This patient population aligns with feedback from payors and providers who have emphasized the need for treatment options in this population.

https://www.globenewswire.com/news-release/2024/09/03/2939571/0/en/ProKidney-Announces-Strategic-Updates-to-its-Phase-3-Program-to-Accelerate-Rilparencel-s-Registrational-Path-to-Potential-Approval-in-the-U-S.html