Current therapeutic options are largely limited to the supportive care with medications until ESRD requires patients to resort to dialysis programs or renal transplantation. The most commonly prescribed medications and supplements to treat CKD patients include Vitamin D, blood pressure controlling medications, phosphorus-lowering medications, and anti-anemic medications. When patients progress to ESRD, dialysis or kidney transplantation is required. For nearly 65% of dialysis patients, life expectancy is estimated at no longer than 5 years. While kidney transplantation provides better outcomes, it is severely limited not only by the shortage of organs, but also by very high morbidity in the first six months post- transplantation.
The magnitude of CKD prevalence and the costs of ESRD treatment demand an innovative response. KidneyCure is developing a novel approach to delay the progression of CKD to ESRD by integrating rejuvenated renal cells into patient tissue to repair damaged renal function.
The Company’s lead product, ANS-001, is based on autologous renal progenitor cells which are cultured and stimulated ex vivo to proliferate and generate three-dimensional cell complexes, as opposed to standard two-dimensional cell culture technologies.
In the future, the Company plans to develop its second cell therapy product, ANS-002, based on urine-derived 3D cell complexes. Urine-derived cell product will allow for a non-invasive, simple procedure for collecting the cells from the patients in large quantities.
Given the tremendous unmet need, lack of optimal therapies and rapidly growing size of CKD population, KidneyCure is evaluating expedited regulatory pathways towards the approval of its proprietary cell-based therapeutic products.
The Company has developed a strong IP portfolio comprising three families of patents associated with (i) the ANS-001 lead product, (ii) products relating to genetically programming kidney cells and (iii) products relating to fetal renal cells.