ProKidney Puts Focus on US Trial for T2D and CKD Cell Therapy Rilparencel
The company also reported that it is discontinuing the phase 3 REGEN-016 (PROACT 2) clinical trial evaluating rilparencel in Spain.
ProKidney has announced a new strategic focus on its phase 3 REGEN-006 (PROACT 1) clinical trial (NCT05099770), which is evaluating rilparencel (also known as REACT), a renal autologous cell therapy, in patients in the United States who have type 2 diabetes (T2D) and chronic kidney disease (CKD).1
On the other hand, the company reported that it is discontinuing the phase 3 REGEN-016 (PROACT 2) clinical trial (NCT05286853), which was evaluating rilparencel in patients with T2D and CKD in Spain. ProKidney stated that based on a comprehensive analysis it does not believe PROACT 2 is necessary to achieve regulatory approval of rilparencel in the US and as such will redirect the resources saved by discontinuing the study. Furthermore, the company determined that rilparencel may be able to receive an expedited approval in the US, pending completed results of PROACT 1, via its regenerative medicine advanced therapy (RMAT) designation, which it attained from the FDA in October 2021. In light of the reorganization of priorities, ProKidney now expects that topline findings from PROACT 1 will be available in the third quarter of 2027.
PROACT 1, which is a randomized, blinded, sham controlled study, is expected to enroll around 685 patients in total. Earlier this year, the study’s protocol was modified to focus on patients with stage 4 CKD and late stage 3b CKD with accompanying albuminuria.
“We decided to prioritize PROACT 1 to accelerate potential US registration and commercial launch,” Bruce Culleton, MD, the chief executive officer of ProKidney, said in a statement.1 “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 US, our highest priority market. 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.”
REGEN-007 (NCT05018416) is an ongoing phase 2 clinical trial (NCT05018416) evaluating rilparencel in patients with CKD caused by diabetes.2 Participants were radnomly assigned into 2 different treatment groups in a 1:1 fashion. In group 1, patients received an injection of rilparencel into 1 kidney and then another injection of rilparencel into the other kidney 3 months later. In group 2, patients initially received an injection of rilparencel into 1 kidney, but only received a second injection into the other kidney if their estimated glomerular filtration rate (eGFR) showed a sustained reduction of 20% or more or if their urine albumin to creatinine ratio showed an increase from baseline of 30% or more and 30 mg/g or more. With a data cutoff of May 7, 2024, ProKidney reported that all 13 patients in group 1 who had 12 months of follow-up after their second injection demonstrated stabilized kidney function for 18 months with an average change in eGFR from baseline of -1.3 ml/min/1.73m2 at 18 months. In terms of safety, there were no serious adverse events deemed related to rilparencel among the 49 patients who received at least 1 injection.
“...The interim results from REGEN-007 are promising and reveal the potential of rilparencel to preserve kidney function in patients with moderate to severe CKD,” Culleton said in a June 2024 statement.2 “This is our first clinical study using bilateral kidney dosing and cryopreserved rilparencel replicating our approach in both PROACT 1 and PROACT 2 phase 3 studies. I am very excited for the next phase of ProKidney’s evolution as we endeavor to demonstrate preservation of kidney function using rilparencel in a patient population with limited therapeutic options.”
