Updated positive interim Phase 2 data demonstrate potential efficacy of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients
Focusing Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure and need for renal replacement therapy
Dr.
Sufficient capital to fund operations into fourth quarter 2025
Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients. Updated interim REACT RMCL-002 study data support continued investigation of REACT’s potential to benefit patients with moderate and high-risk diabetic CKD. The updated data include information from 83 patients enrolled in the RMCL-002 study. All patients had Stage 3 or 4 CKD caused by type 2 diabetes. The ongoing Phase 2 clinical study assessed adverse events and changes in kidney function as measured by estimated glomerular filtration rate (eGFR), as primary study endpoints. The dataset revealed a safety profile in line with previous Phase 1 & 2 REACT trials, with REACT showing a safety profile similar to that of a kidney biopsy. Overall, the updated Phase 2 trial data showed preservation of kidney function in several patient groups with advanced CKD caused by type 2 diabetes, with the most notable potential benefit shown in patients who had the highest risk of kidney failure (CKD Stage 4 with severe albuminuria), where there remains a significant unmet clinical need.
Focusing ongoing Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure and need for renal replacement therapy. Based on these emerging results, the Company plans to update its ongoing proact 1 Phase 3 clinical study (REGEN-006) protocol to focus on patients with higher risk of kidney failure. In the proact 1 Phase 3 clinical study we will modify the eGFR enrollment range from the current range of ≥20 to ≤ 50 ml/min/1.73m2 to a new range of ≥20 to ≤ 35 ml/min/1.73m2, to focus on the most severe patients, to better align with RMCL-002 results and clinical feedback. The Company does not intend to modify the eGFR enrollment range for its second Phase 3 trial, proact 2 (REGEN-016), which is currently ≥20 to ≤ 44 ml/min/1.73m2. Maintaining the eGFR enrollment range of proact 2, which includes the CKD Stage 3B population, will enable the Company to seek a broader commercial label. The modification to the eGFR enrollment range to our proact 1 Phase 3 clinical study will cause a delay in enrollment of this study, and we expect to resume enrollment during the first half of 2024.
The Company is temporarily pausing manufacturing until the first half of 2024, while the Company optimizes its capabilities to meet EU and global standards for its Phase 3 program and future commercial manufacturing. The Company will work to implement these manufacturing and documentation improvements concurrently with the 006 pause for protocol changes such that it expects proact 1 will resume, and proact 2 will commence enrollment in the first half of 2024.
Dr.
“We’re leveraging a novel renal autologous cell therapy to improve care in a population of CKD patients with little to no options other than dialysis, and
Commenting on his new role,
Dr. Culleton earned a Doctor of Medicine degree from Memorial University of
Sufficient capital to fund operations into fourth quarter 2025.
The Company expects to provide full data of its RMCL-002 Phase 2 study in the first half of 2024 and interim results on its ongoing RMCL-007 Phase 2 study in mid- 2024 and full results in the first half of 2025. The Company will provide additional guidance regarding the timing of its Phase 3 programs during the conference call on
Investor Conference Call
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This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. ProKidney’s 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 “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” 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’s expectations with respect to financial results and expected cash runway, future performance, development and commercialization of products, if approved, the potential benefits and impact of the Company’s products, if approved, potential regulatory approvals, the size and potential growth of current or future markets for the Company’s products, if approved, the advancement of the Company’s development programs into and through the clinic and the expected timing for reporting data, the making of regulatory filings, updating clinical trial protocols, or achieving other milestones related to the Company’s product candidates, and the advancement and funding of the Company’s developmental programs generally. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the inability to maintain the listing of the Company’s Class A ordinary shares on the Nasdaq; 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 and retain its key employees; the risk of downturns and a changing regulatory landscape in the highly competitive biotechnology industry; the inability of the Company to raise financing in the future; the inability of the Company to obtain and maintain regulatory clearances or approvals 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’s products, if approved, and its ability to serve those markets, either alone or in partnership with others; the Company’s estimates regarding expenses, future revenue, capital requirements and needs for additional financing; the Company’s financial performance; the Company’s 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 COVID-19 or geo-political conflict such as the war in
Contacts
Corporate:
SVP, Investor Relations
Glenn.Schulman@prokidney.com
Investors:
Daniel@lifesciadvisors.com
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