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Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, has announced the publication in the prestigious peer-reviewed journal Kidney Medicine regarding the company’s proprietary DSR 2.0, used in its Direct Sodium Removal program, a potential therapy for the treatment of cardiorenal syndrome and diuretic resistance in heart failure.
Dr. Jeffrey Testani, Associate professor at Yale University commented: “This manuscript describes the pre-clinical to first in-human development of the first solution specifically designed to remove sodium from our patients. All commercially available peritoneal solutions were designed with a primary goal of cleaning toxins from the blood, whereas DSR 2.0 was created to specifically meet the unmet clinical need of removing salt and water. The results were truly impressive with ~4X greater sodium removal with DSR 2.0 compared to a commercially available solution. This new tool will allow significant improvement in the care of our diuretic resistant cardio-renal syndrome patients”.
Ian Crosbie, CEO of Sequana Medical, added: “We are delighted with this publication highlighting the improved safety and efficacy of our proprietary DSR 2.0 vs dextrose-based approaches. These results build on clinical proof of concept published in European Journal of Heart Failure for DSR as a potential drug therapy for diuretic resistance and cardiorenal syndrome in heart failure using our DSR 1.0 product. The results of the first patients in the US MOJAVE study using our advanced DSR 2.0 product support the enhanced efficacy demonstrated in this excellent paper. We believe DSR’s ability to virtually eliminate the need for loop diuretics for many months post-treatment represents a breakthrough in treatment options, and address one of the leading drivers of healthcare costs.”
The paper details pre-clinical and clinical studies to develop an optimised solution for removal of sodium and water. This builds upon the initial proof of concept studies published in Circulation demonstrating that DSR 1.0 increased sodium removal four-fold compared to commercially available peritoneal dialysis solutions. In previous experiments in humans, one litre of DSR 1.0 with a dwell of two hours removed on average 4.5g of sodium with a net ultrafiltration volume of 700mL; whereas in this paper, 0.5L of DSR 2.0 with a dwell of 24 hours removed ~9g of sodium with a net ultrafiltration volume of 2,500mL.
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