ProKidney Suspends One Phase 3 CKD Cell Therapy Trial Deemed Surplus for FDA Approval

ProKidney has suspended one of its Phase 3 trials for a cell therapy aimed at treating chronic kidney disease (CKD), as it is considered surplus to requirements for FDA approval.
The decision was made after reviewing Phase 2 interim data, which showed the therapy's potential to preserve kidney function in patients with moderate and high-risk diabetic CKD.
The company plans to update the protocol of its ongoing Phase 3 clinical trial, REGEN-006, to focus on the most severe CKD patients.
The trial's enrollment range will be modified to include patients with an estimated glomerular filtration rate (eGFR) between ≥20ml/min/1.73m² to ≤ 35ml/min/1.73m².
ProKidney has also paused the manufacturing of its cell therapy, React, until the first half of 2024 due to certain deficiencies identified in the documentation of the quality management systems at its EU manufacturing site.
The company has a cash runway of $396 million, expected to fund operations into Q4 2025, and a market cap of $1.8 billion.