WINSTON-SALEM, N.C., May 20, 2022 (GLOBE NEWSWIRE) -- ProKidney LP (ProKidney), a leading clinical-stage cellular therapeutics company focused on the treatment of chronic kidney disease (CKD) and the prevention of both end-stage renal disease (ESRD) and the need for dialysis, today announced that Tim Bertram, PhD, Chief Executive Officer, will present at the following investor conferences:
- UBS Global Healthcare ConferenceMonday, May 23 at 1:15 p.m. Eastern Daylight Time
- Jefferies Healthcare Conference Wednesday, June 8 at 8:30 a.m. Eastern Daylight Time
A live webcast of Dr. Bertram’s presentation at the UBS Global Healthcare conference will be available on the ProKidney website at www.prokidney.com.
Investors attending the Jefferies Healthcare Conference who wish to meet with ProKidney management are encouraged to contact their Jefferies representative.
About ProKidneyProKidney, a pioneer in the treatment of CKD through innovation in cellular therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, REACT™ (Renal Autologous Cell Therapy), is a first-of-its-kind, patented, disease-modifying, autologous cellular therapy with the potential not only to slow and stabilize the progression of CKD, but in some cases drive meaningful improvement in kidney function. REACT™ has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting the Phase 3 clinical program that launched on schedule in January 2022. On January 18, 2022, ProKidney announced that it would become a publicly traded company via a business combination with Social Capital Suvretta Holdings Corp. III (Nasdaq: DNAC). For more information, visit www.prokidney.com.
About The Phase 3 Clinical Program for REACT™ In October 2021, the FDA granted ProKidney’s REACT™ Regenerative Medicine Advanced Therapy (RMAT) designation, after reviewing more than seven years of data collected from over 100 REACT™–treated patients with stages 3/4 diabetic CKD and moderate-to-severe albuminuria and guided ProKidney on a registrational clinical program and potency assay development. This program is designed to generate efficacy and safety data in two randomized, sham-controlled, blinded studies with a primary composite endpoint under a Time-to-Event design. The trials in total will include approximately 1,200 subjects globally, and a clinical evidence package based on this design may provide the necessary evidence of safety and effectiveness to support a Biologics License Application (BLA) for commercialization of REACT™.
The Phase 3 program will be conducted in multiple centers in the United States, Europe, Latin America, and Asia Pacific. Study subject demographics will be consistent with previous trials involving REACT™, including patients at high-risk-of-end-stage kidney disease: Type 2 diabetic mellitus, CKD stage 3/4, not on renal dialysis, eGFR 20-50 ml/min/1.73 m2, and UACR ranging from 30-5000 mg/g. The robust safety profile of REACT™ after two injections in the same kidney in clinical studies thus far supports an effort to enhance efficacy potential by injecting subjects in both kidneys in the Phase 3 program. This broader injection pattern holds the potential to achieve greater efficacy as the therapy will be delivered into the patients’ two kidneys – 2x the kidney mass as compared to Phase 2.
Study subjects in the treatment arm will undergo a kidney biopsy and then be injected in each kidney once with a three-month interval in between injections. Study subjects randomized to the standard of care arm of the study will receive sham biopsies and injections. Following either the second REACT™ or sham injections, subjects in the treatment or standard of care arms will be followed clinically until they reach one of the three components of the primary composite endpoint. Specifically, the primary composite endpoint for this Phase 3 clinical program 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;
- eGFR