We are a clinical-stage biotechnology company with a transformative proprietary cell therapy platform with the potential for treating Chronic Kidney Disease using a patient’s own cells.
Our approach seeks to redefine the treatment of Chronic Kidney Disease (CKD), shifting the emphasis away from management of kidney failure, to the restoration or improvement of kidney function to stop or delay progression of CKD. Our lead product candidate, REACT, is designed to stabilize or improve kidney function in a CKD patient’s diseased kidneys. REACT is an investigational cell therapy product that includes selected renal cells (SRCs) prepared from the patient’s renal biopsy tissue.
SRCs are formulated into a product for reinjection into the patient’s kidney using a minimally invasive outpatient procedure. Because REACT is a personalized treatment composed of cells prepared from a patient’s own kidney, there is no need for treatment with immunosuppressive therapies, which are required during a patient’s lifetime when a patient receives a kidney transplant from another, allogeneic donor.
REACT Clinical Trials Are Underway
REACT has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for slowing the progression of Chronic Kidney Disease and improving kidney function. We are currently conducting a Phase 3 development program and multiple Phase 2 clinical trials for REACT in subjects with moderate to severe diabetic kidney disease. We are also conducting a Phase 1 clinical trial for REACT in subjects with congenital anomalies of the kidney and urinary tract (“CAKUT”). REACT has been well tolerated by subjects with moderate to severe diabetic kidney disease in Phase 1 and 2 clinical testing to date. Early studies indicate a potential for REACT to stabilize, or even improve, renal function.
We are initially pursuing the development of REACT for use in moderate to severe CKD patients in the United States and selected countries around the world with diabetes as the primary cause. We estimate that approximately 38-39 million adults, representing approximately 15% of the U.S. adult population, currently suffer from CKD, of which approximately 17-18 million patients have stage 3 or 4 CKD, and approximately 13.4 million patients have stage 3 or 4 CKD that is caused by diabetes (approximately 8.3 million) or hypertension (approximately 5.1 million). With respect to those patients with CKD caused primarily by diabetes, we estimate that approximately 4-5 million patients would be eligible to be treated with REACT, should it be approved by the FDA for commercial use in the U.S.