ProKidney Reports Statistically and Clinically Significant Topline Results for the Phase 2 REGEN-007 Trial Evaluating Rilparencel in Patients with Chronic Kidney Disease and Diabetes
ProKidney (NASDAQ: PROK) announced significant positive topline results from its Phase 2 REGEN-007 trial evaluating rilparencel for chronic kidney disease (CKD) and diabetes. In Group 1 (n=24), patients receiving two rilparencel injections showed a 78% improvement in annual eGFR slope decline, from -5.8 to -1.3 mL/min/1.73m2 (p<0.001). Group 2 (n=25), testing a conditional second-dose approach, demonstrated a 50% improvement in kidney function decline.
The therapy demonstrated a favorable safety profile with no rilparencel-related serious adverse events. ProKidney plans to present complete results at ASN's 2025 Kidney Week and has an upcoming FDA Type B meeting to confirm using eGFR slope as a surrogate endpoint for accelerated approval of their ongoing Phase 3 PROACT 1 study.
ProKidney (NASDAQ: PROK) ha annunciato risultati positivi significativi preliminari dal suo studio di Fase 2 REGEN-007, che valuta rilparencel per la malattia renale cronica (CKD) e il diabete. Nel Gruppo 1 (n=24), i pazienti trattati con due iniezioni di rilparencel hanno mostrato un miglioramento del 78% nel declino annuale della pendenza eGFR, passando da -5,8 a -1,3 mL/min/1,73m虏 (p<0,001). Il Gruppo 2 (n=25), che ha testato un approccio con una seconda dose condizionata, ha evidenziato un miglioramento del 50% nel declino della funzionalit脿 renale.
La terapia ha dimostrato un profilo di sicurezza favorevole, senza eventi avversi gravi correlati a rilparencel. ProKidney prevede di presentare i risultati completi alla Kidney Week 2025 dell'ASN e ha in programma un incontro di tipo B con la FDA per confermare l'uso della pendenza eGFR come endpoint surrogato per l'approvazione accelerata del loro studio di Fase 3 PROACT 1 in corso.
ProKidney (NASDAQ: PROK) anunci贸 resultados positivos significativos preliminares de su ensayo de Fase 2 REGEN-007, que eval煤a rilparencel para la enfermedad renal cr贸nica (ERC) y la diabetes. En el Grupo 1 (n=24), los pacientes que recibieron dos inyecciones de rilparencel mostraron una mejora del 78% en la pendiente anual de declive del eGFR, pasando de -5,8 a -1,3 mL/min/1,73m虏 (p<0,001). El Grupo 2 (n=25), que prob贸 un enfoque de segunda dosis condicional, demostr贸 una mejora del 50% en la disminuci贸n de la funci贸n renal.
La terapia mostr贸 un perfil de seguridad favorable sin eventos adversos graves relacionados con rilparencel. ProKidney planea presentar los resultados completos en la Kidney Week 2025 de ASN y tiene una pr贸xima reuni贸n Tipo B con la FDA para confirmar el uso de la pendiente de eGFR como un endpoint sustituto para la aprobaci贸n acelerada de su estudio en curso de Fase 3 PROACT 1.
ProKidney (NASDAQ: PROK)電� 毵岇劚 鞁犾灔 歆堩櫂(CKD) 氚� 雼闺嚚氤� 旃橂毳� 鞙勴暅 rilparencel 韽夑皜毳� 鞙勴暅 2靸� REGEN-007 鞛勳儊鞁滍棙鞐愳劀 欷戩殧頃� 旮嶌爼鞝� 齑堦赴 瓴瓣臣毳� 氚滍憸頄堨姷雼堧嫟. 1攴鸽９ (n=24)鞐愳劀電� rilparencel 2須� 韴棳 頇橃瀽霌れ澊 鞐瓣皠 eGFR 臧愳唽鞙澊 -5.8鞐愳劀 -1.3 mL/min/1.73m虏搿� 78% 臧滌劆霅橃棃鞙茧┌ (p<0.001) 2攴鸽９ (n=25)鞐愳劀電� 臁瓣贝攵� 2須� 韴棳 氚╈嫕鞚� 鞁滍棙頃橃棳 鞁犾灔 旮半姤 臧愳唽臧� 50% 臧滌劆霅橃棃鞀惦媹雼�.
鞚� 旃橂氩曥潃 rilparencel 甏�霠� 欷戨寑頃� 鞚挫儊 氚橃潙 鞐嗢澊 鞎堨爠靹� 頂勲韺岇澕鞚� 鞏戫樃頃潉 氤挫榾鞀惦媹雼�. ProKidney電� ASN 2025 鞁犾灔 欤缄皠 頄夓偓鞐愳劀 鞕勳爠頃� 瓴瓣臣毳� 氚滍憸頃� 鞓堨爼鞚措┌, 歆勴枆 欷戩澑 3靸� PROACT 1 鞐瓣惮鞚� 臧�靻� 鞀轨澑 鞙勴暣 eGFR 臧愳唽鞙潉 雽�毽� 韽夑皜 歆�響滊 靷毄頃橂姅 瓴冹潉 頇曥澑頃橁赴 鞙勴暣 FDA鞕� Type B 氙疙寘鞚� 瓿勴殟頃橁碃 鞛堨姷雼堧嫟.
ProKidney (NASDAQ : PROK) a annonc茅 des r茅sultats positifs significatifs pr茅liminaires de son essai de phase 2 REGEN-007 茅valuant le rilparencel pour la maladie r茅nale chronique (MRC) et le diab猫te. Dans le Groupe 1 (n=24), les patients ayant re莽u deux injections de rilparencel ont montr茅 une am茅lioration de 78% du d茅clin annuel de la pente eGFR, passant de -5,8 脿 -1,3 mL/min/1,73m虏 (p<0,001). Le Groupe 2 (n=25), testant une approche de seconde dose conditionnelle, a d茅montr茅 une am茅lioration de 50% du d茅clin de la fonction r茅nale.
Le traitement a pr茅sent茅 un profil de s茅curit茅 favorable sans 茅v茅nements ind茅sirables graves li茅s au rilparencel. ProKidney pr茅voit de pr茅senter les r茅sultats complets lors de la Kidney Week 2025 de l鈥橝SN et a une prochaine r茅union de type B avec la FDA pour confirmer l鈥檜tilisation de la pente eGFR comme crit猫re de substitution pour une approbation acc茅l茅r茅e de leur 茅tude de phase 3 PROACT 1 en cours.
ProKidney (NASDAQ: PROK) gab bedeutende positive Zwischenergebnisse aus der Phase-2-Studie REGEN-007 bekannt, in der rilparencel bei chronischer Nierenerkrankung (CKD) und Diabetes untersucht wird. In Gruppe 1 (n=24) zeigten Patienten, die zwei Injektionen von rilparencel erhielten, eine 78% Verbesserung der j盲hrlichen eGFR-Abnahme, von -5,8 auf -1,3 mL/min/1,73m虏 (p<0,001). Gruppe 2 (n=25), die einen bedingten Zweitdosisansatz testete, zeigte eine 50% Verbesserung des Nierenfunktionsverlusts.
Die Therapie zeigte ein g眉nstiges Sicherheitsprofil ohne schwerwiegende unerw眉nschte Ereignisse im Zusammenhang mit rilparencel. ProKidney plant, die vollst盲ndigen Ergebnisse auf der ASN Kidney Week 2025 vorzustellen und hat ein bevorstehendes FDA Type-B-Meeting, um die Verwendung der eGFR-Abnahme als Surrogat-Endpunkt f眉r die beschleunigte Zulassung der laufenden Phase-3-Studie PROACT 1 zu best盲tigen.
- Statistically significant 78% improvement in kidney function decline in Group 1 (p<0.001)
- Strong safety profile with no rilparencel-related serious adverse events
- Evidence of dose response in Group 2 with 50% improvement
- FDA confirmed accelerated approval pathway availability
- 63% of Group 1 patients met key Phase 3 PROACT 1 inclusion criteria with similar efficacy
- Group 2 results did not achieve statistical significance (p=0.085)
- Full trial results are being held until ASN 2025 Kidney Week presentation
- FDA approval for eGFR slope as surrogate endpoint still pending confirmation
Insights
ProKidney's rilparencel shows 78% improvement in kidney function decline rate in CKD patients with diabetes, bolstering Phase 3 prospects.
ProKidney's Phase 2 REGEN-007 trial results represent a significant breakthrough in CKD treatment. The data shows that patients receiving two rilparencel injections (Group 1) experienced a 78% reduction in the annual rate of kidney function decline, with eGFR slope improving from -5.8 to -1.3 mL/min/1.73m虏, a difference of 4.6 mL/min/1.73m虏 (
What makes these results particularly compelling is the dose-response relationship observed between Group 1 (two scheduled injections) and Group 2 (conditional second injection). Group 2 showed a 50% reduction in decline rate (from -3.4 to -1.7 mL/min/1.73m虏), though not reaching statistical significance (
The safety profile appears favorable with no rilparencel-related serious adverse events reported, comparable to a kidney biopsy procedure. This is crucial for a therapy targeting chronic administration in a vulnerable population.
Most promising for investors is that 63% of Group 1 patients met key inclusion criteria for the ongoing Phase 3 PROACT 1 trial and showed similar efficacy results, suggesting the positive findings may translate to the larger pivotal study. The upcoming FDA Type B meeting to confirm eGFR slope as a surrogate endpoint for accelerated approval represents a potential regulatory catalyst that could expedite rilparencel's path to market.
For patients with advanced CKD and diabetes, these results offer hope for a therapy that could significantly slow disease progression in a condition with limited treatment options beyond standard of care medications like ACEi/ARBs and SGLT2 inhibitors.
- Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology 2025 Kidney Week as a late-breaking clinical trial
- In Group 1 (n=24), kidney function stabilized in patients randomized to receive two rilparencel injections (one in each kidney). The annual decline in eGFR slope improved by
78% from -5.8 mL/min/1.73m2 in the pre-injection period to -1.3 mL/min/1.73m2 in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference was statistically significant (p<0.001) and clinically meaningful - In Group 2 (n=25), patients were randomized to receive a single rilparencel injection followed by a second injection only if kidney function worsened and a re-dosing trigger was met. The annual decline in eGFR slope improved by
50% from -3.4 mL/min/1.73m2 in the pre-injection period to -1.7 mL/min/1.73m2 in the period following the last rilparencel injection. This 1.7 mL/min/1.73m2 per year difference was not statistically significant (p=0.085) but suggests evidence of a dose response - No rilparencel-related serious adverse events were observed; the safety profile was consistent with previously reported study results and comparable to a kidney biopsy
- FDA Type B meeting set for this summer to confirm ProKidney鈥檚 approach to using eGFR slope as the surrogate endpoint in the ongoing Phase 3 PROACT 1 study for accelerated approval
WINSTON-SALEM, N.C., July 08, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (鈥淧roKidney鈥� or the 鈥淐ompany"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today reported statistically significant and clinically meaningful positive topline results from the full Group 1 modified intent-to-treat (mITT) population of the Phase 2 REGEN-007 trial evaluating rilparencel in patients with CKD and diabetes. Rilparencel is an autologous cellular therapy that has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food & Drug Administration (FDA) and is currently being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) trial to demonstrate the therapy鈥檚 potential to preserve kidney function in patients with advanced CKD and type 2 diabetes.
鈥淲e are very encouraged by the REGEN-007 topline results that demonstrated a robust improvement in eGFR slope following treatment with rilparencel in Group 1 as well as evidence of a dose response in Group 2. These data bolster our confidence in the design of our ongoing Phase 3 PROACT 1 study given the similarity between the dosing regimen in REGEN-007 Group 1 and PROACT 1. It is also worth noting that 15 of the 24 patients in Group 1 (
Phase 2 REGEN-007 Overview and Topline Results
REGEN-007 is a multi-center Phase 2 open-label 1:1 randomized two-arm trial in patients with diabetes, CKD, and an estimated glomerular filtration rate (eGFR) of 20-50 mL/min/1.73m虏. At randomization, patients were assigned to one of two treatment groups using different dosing regimens. Group 1 replicated the dosing schedule of the ongoing Phase 3 PROACT 1 study in which patients received two scheduled rilparencel injections (one in each kidney), approximately three months apart. Group 2 tested an exploratory dosing regimen to investigate whether disease progression triggers, rather than a time-based trigger, could optimize multiple administrations of rilparencel. In Group 2, patients received a single rilparencel injection in one kidney and a second injection in the contralateral kidney only if triggered by a sustained eGFR decline from baseline of 鈮�
The prespecified primary endpoint for REGEN-007 is the difference in annual eGFR slope (calculated using a linear mixed effects model) in the pre-injection period versus the period following the last rilparencel injection. The pre-injection period included all historical eGFR values collected up to 24 months before the screening visit as well as the on-study central laboratory eGFR results prior to first rilparencel injection. The period following the last injection included eGFR values from the last rilparencel injection to the end of study (EOS) visit. Median follow-up after the last injection was approximately 18 months in both Group 1 and Group 2.
Fifty-three patients were randomized in the study, of whom 49 patients (mITT population) received at least one rilparencel injection. Four patients did not receive any rilparencel injections. The majority of patients were male (
| 听 | 听 | 听 | Annual eGFR Slope (mL/min/1.73m2) | 听 | ||||
| 听 | Group | N (mITT) | Pre inj | Post last inj | Absolute benefit | Relative benefit | 听 | |
| 听 | 1 | 24 | -5.8 | -1.3 | 4.6 | 78% | 听 | |
| 听 | 2 | 25 | -3.4 | -1.7 | 1.7 | 50% | 听 | |
| 听 | 听 | 听 | 听 | 听 | 听 | 听 | 听 | |
In Group 1 (n=24), kidney function stabilized after receiving rilparencel. The annual decline in eGFR slope improved by
In Group 2 (n=25), the annual change in kidney function as measured by eGFR slope was -3.4 mL/min/1.73m2 in the pre-injection period versus -1.7 mL/min/1.73m2 in the period following the last rilparencel injection, resulting in an improvement of
No rilparencel-related serious adverse events were observed across all patients in the study who received at least one rilparencel injection (n=49). The safety profile was consistent with previously reported study results and comparable to a kidney biopsy.
Full results from REGEN-007 are being held and will be submitted to the American Society of Nephrology (ASN) 2025 Kidney Week as a late-breaking clinical trial.
Phase 3 PROACT 1 Regulatory Progress
As previously communicated, the FDA confirmed during a Type B meeting in Q4 2024 that the accelerated approval pathway is available for rilparencel if an acceptable surrogate endpoint, such as eGFR slope, is used. ProKidney has an upcoming FDA Type B meeting this summer to confirm the approach to using eGFR slope as the surrogate endpoint for accelerated approval. Additional details are expected in mid-2025.
About Chronic Kidney Disease
CKD is a progressive condition characterized by the gradual decline of kidney function, which can ultimately lead to end-stage kidney disease (ESKD) requiring dialysis or transplantation. An estimated 37 million adults in the U.S. have CKD, though many remain undiagnosed in the early stages. Diabetes is the leading cause of CKD, and individuals with both conditions face significantly elevated risks of cardiovascular events, hospitalization, and mortality. ProKidney is developing rilparencel for patients with Stage 3b/4 CKD and diabetes, a population that includes 1 to 2 million people in the U.S. While current treatment options aim to slow disease progression, there remains a substantial unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in patients with advanced CKD.
About the Phase 3 REGEN-006 (PROACT 1) Clinical Trial
REGEN-006 is an ongoing Phase 3, randomized, blinded, sham controlled safety and efficacy study of rilparencel in subjects with advanced CKD and type 2 diabetes. The study protocol was amended in 1H 2024 to focus on a subset of patients with Stage 4 CKD (eGFR 20-30 mL/min/1.73m虏) and late Stage 3b CKD (eGFR 30-35 mL/min/1.73m虏) with accompanying albuminuria (UACR less than 5,000 mg/g for patients with eGFR 20-30 mL/min/1.73m虏听and 300-5,000 mg/g for patients with eGFR 30-35 mL/min/1.73m虏). The total planned enrollment is approximately 685 subjects. Subjects are randomized (1:1) to the treatment group and the sham control group prior to kidney biopsy or a sham biopsy procedure, respectively. The primary objective is to assess the efficacy of up to two rilparencel injections (one in each kidney) using a minimally invasive percutaneous approach. The primary composite endpoint is the time from first injection to the earliest of: at least
About ProKidney Corp.
ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney鈥檚 lead product candidate, rilparencel (also known as REACT庐), is a first-in-class, patented, proprietary autologous cellular therapy being evaluated for its potential to preserve kidney function in diabetic patients at high risk of kidney failure. Rilparencel has received RMAT designation from the FDA. For more information, please visit听.
Forward-Looking Statements
This press release includes 鈥渇orward-looking statements鈥� within the meaning of the 鈥渟afe harbor鈥� provisions of the Private Securities Litigation Reform Act of 1995. ProKidney鈥檚 actual results may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as 鈥渆xpect,鈥� 鈥渆stimate,鈥� 鈥減roject,鈥� 鈥渂udget,鈥� 鈥渇orecast,鈥� 鈥渁nticipate,鈥� 鈥渋ntend,鈥� 鈥減lan,鈥� 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渃ould,鈥� 鈥渟hould,鈥� 鈥渂elieves,鈥� 鈥減redicts,鈥� 鈥減otential,鈥� 鈥渃ontinue,鈥� and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company鈥檚 beliefs that the FDA agrees that the Company鈥檚 Phase 3 REGEN-006 (PROACT 1) trial could be sufficient to support a potential BLA submission and full regulatory approval and that the Company could consider using eGFR slope as a surrogate endpoint on an accelerated approval pathway for rilparencel, expectations with respect to financial results and expected cash runway, including the Company鈥檚 expectation that current cash will support operating plans into 2027, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company鈥檚 products, if approved, potential regulatory approvals, the size and potential growth of current or future markets for the Company鈥檚 products, if approved, the advancement of the Company鈥檚 development programs into and through the clinic and the expected timing for reporting data, the making of regulatory filings or achieving other milestones related to the Company鈥檚 product candidates, and the advancement and funding of the Company鈥檚 developmental programs, generally. Most of these factors are outside of the Company鈥檚 control and are difficult to predict. Factors that may cause such differences include, but are not limited to: disruptions to our business or that may otherwise materially harm our results of operations or financial condition as a result of our recent domestication to the United States; the inability to maintain the listing of the Company鈥檚 Class A common stock on Nasdaq; the inability of the Company鈥檚 Class A common stock to remain included in various indices and the potential negative impact on the trading price of the Class A common stock if excluded from such indices; the inability to implement business plans, forecasts, and other expectations or identify and realize additional opportunities, which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the risk that results of the Company鈥檚 clinical trials may not support approval; the risk that the FDA could require additional studies before approving the Company鈥檚 drug candidates; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of Company to compete with other companies currently marketing or engaged in the biologics market and in the area of treatment of kidney diseases; the size and growth potential of the markets for the Company鈥檚 products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company鈥檚 estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company鈥檚 financial performance; the Company鈥檚 intellectual property rights; uncertainties inherent in cell therapy research and development, including the actual time it takes to initiate and complete clinical studies and the timing and content of decisions made by regulatory authorities; the fact that interim results from our clinical programs may not be indicative of future results; the impact of geo-political conflict on the Company鈥檚 business; and other risks and uncertainties included under the heading 鈥淩isk Factors鈥� in the Company鈥檚 most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. The Company cautions readers that the foregoing list of factors is not exclusive and cautions readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
Investor Contacts:
ProKidney
Ethan Holdaway
LifeSci Advisors, LLC
Daniel Ferry
1 Difference in values is due to rounding.
FAQ
What were the key results of ProKidney's (PROK) REGEN-007 Phase 2 trial?
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