NEW YORK – ProKidney is discontinuing one of its Phase III clinical trials that it no longer believes is necessary to garner US Food and Drug Administration approval for rilparencel, its cell therapy candidate for chronic kidney disease.
The company conducted a review involving former regulatory officials to identify the best path to bring rilparencel to market for type 2 diabetes and advanced chronic kidney disease. Rilparencel, an autologous cell therapy prepared using patients' own kidney cells, is designed to preserve kidney function by stabilizing estimated glomerular filtration rate or slowing its decline among patients with chronic kidney disease due to type 2 diabetes.
ProKidney had been assessing rilparencel in two trials, the Phase III REGEN-006 (PROACT 1) trial and the Phase III REGEN-016 (PROACT 2) trial, but the review suggested to the company that PROACT 2, which was focusing on patients outside the US, is not needed for initial US registration.
The review concluded ProKidney could seek initial FDA approval for rilparencel under the expedited approval pathway using only PROACT 1 trial results because of its Regenerative Medicine Advanced Therapy designation, which was awarded in 2021.
PROACT 1 is enrolling 685 patients with type 2 diabetes and advanced CKD, half of whom receive rilparencel injections in different kidneys three months apart and half of whom receive sham treatments, to assess treatment efficacy.
With these changes, ProKidney estimates that it has reduced expenses by $150 million to $175 million and that it has enough cash to support operations into the beginning of 2027. It now expects top-line results from its Phase III program by Q3 2027.