· Article published online in American Journal of Nephrology; to be included in future print edition
Winston-Salem, NC, January 27, 2022 — ProKidney LP (“ProKidney”), a leading clinical-stage cellular therapeutics company focused on chronic kidney disease (“CKD”), today announced the publication of the trial design of its Phase II clinical study of its novel Renal Autologous Cell Therapy (REACT®) in the American Journal of Nephrology. The paper, titled Novel Renal Autologous Cell Therapy for Type 2 Diabetes Mellitus Chronic Diabetic Kidney Disease: Clinical Trial Design, was published online and will appear in a future print edition of the Journal (DOI: 10.1159/000520231).
“Renal autologous cell therapy, or REACT®, is a potentially groundbreaking treatment for CKD patients, a population in dire need of new, more effective therapeutic options,” said Joseph Stavas, M.D., ProKidney’s SVP Clinical Development and lead author of the manuscript. “Publication of the study design in a prestigious peer-reviewed journal highlights the importance of the trial and the implications for advancing care in this patient population. We have generated compelling interim data from the study and look forward to submitting the final results for presentation at a future medical meeting.”
The study is a prospective, multicenter, randomized control, open-label Phase II clinical trial that enrolled a total of 83 subjects ages 30-80 with Type 2 diabetic kidney disease. Following a kidney biopsy, subjects were randomized 1:1 to receive either active treatment with REACT® or optimized standard of care. Patients in the REACT® cohort receive two injections to be given six months apart in the same kidney that was biopsied. Subjects in the standard of care treatment arm receive optimal lifestyle and contemporaneous pharmacologic management of their disease (including SGLT2s, GLP-1, finerenone) for 12 months before crossing over to receive REACT® treatment. The primary safety endpoint is assessment of procedure- and REACT®-related adverse events through 24 months after the last REACT® dose. The primary efficacy endpoint is a measurement of estimated glomerular filtration rate (eGFR) from baseline through 24 months after the last REACT® dose. Additional information can be found at http://clinicaltrials.gov/ct2/show/NCT02836574.
REACT® has the potential to not only slow the progression of CKD, but in some cases drive meaningful improvement in kidney function – a groundbreaking first in CKD therapies.
A cell therapy product produced from a patient’s own kidney cells, REACT® comprises a proprietary mixture of progenitor cells that have been grown and selected, so they can be placed back into the patient’s kidney. This minimally invasive procedure, starting with a standard biopsy, provides the cells that harness the body’s intrinsic ability to repair and restore damaged kidney tissue. The outpatient reinjection procedure has been shown to be safer than contemporary biopsy and renal failure treatment options, such as dialysis and organ transplant.
ProKidney, a pioneer in the treatment of chronic kidney disease (CKD) through innovations 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 to not only 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 an immediate start to its Phase 3 clinical program, which 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.
Additional Information and Where to Find It
In connection with the proposed transaction, Social Capital Suvretta Holdings Corp. III (“SCS”) intends to file a preliminary proxy statement and a definitive proxy statement with the U.S. Securities and Exchange Commission (the “SEC”). SHAREHOLDERS OF SCS ARE ADVISED TO READ, WHEN AVAILABLE, THE PRELIMINARY PROXY STATEMENT, ANY AMENDMENTS THERETO, THE DEFINITIVE PROXY STATEMENT AND ALL OTHER RELEVANT DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. HOWEVER, THIS DOCUMENT WILL NOT CONTAIN ALL THE INFORMATION THAT SHOULD BE CONSIDERED CONCERNING THE PROPOSED TRANSACTION. IT IS ALSO NOT INTENDED TO FORM THE BASIS OF ANY INVESTMENT DECISION OR ANY OTHER DECISION IN RESPECT OF THE PROPOSED TRANSACTION. When available, the definitive proxy statement will be mailed to the shareholders of SCS as of a record date to be established for voting on the proposed transaction. Shareholders will also be able to obtain copies of the preliminary proxy statement, the definitive proxy statement and other documents filed with the SEC that will be incorporated by reference therein, without charge, once available, at the SEC’s website at http://www.sec.gov.
The documents filed by SCS with the SEC also may be obtained free of charge at SCS’s website at https://socialcapitalsuvrettaholdings.com/dnac or upon written request to 2850 W. Horizon Ridge Parkway, Suite 200, Henderson, NV 89052.
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SCS and ProKidney, LP and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from SCS’s shareholders in connection with the proposed transaction. A list of the names of such directors and executive officers and information regarding their interests in the proposed transaction between ProKidney and SCS will be contained in the proxy statement when available. You may obtain free copies of these documents as described in the preceding paragraph.
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Robert Flamm, Ph.D.