Sequana Medical NV has announced the publication of data highlighting the superiority of its proprietary DSR 2.0 (Direct Sodium Removal) solution over traditional peritoneal dialysis methods. The research, published in Kidney Medicine, details the preclinical and first-in-human development of DSR 2.0, a potential therapy for cardiorenal syndrome and diuretic resistance in heart failure.
Enhanced Sodium and Water Removal
DSR 2.0 is a sodium-free dextrose/icodextrin solution designed to increase ultrafiltration and sodium removal. The study demonstrated that DSR 2.0 achieved more than threefold greater sodium removal compared to commercially available peritoneal dialysis solutions. This is particularly significant as current peritoneal solutions primarily focus on toxin removal, leaving a clinical gap in effective sodium and water management.
Dr. Jeffrey Testani, Associate Professor at Yale University and scientific advisor to Sequana, stated, "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. This new tool will allow significant improvement in the care of our diuretic-resistant cardio-renal syndrome patients."
Clinical Implications and MOJAVE Study
Data from Sequana’s Phase I/II MOJAVE study indicated that DSR therapy improved diuretic response in patients with diuretic-resistant heart failure, potentially reducing or eliminating the need for loop diuretics. This is a crucial advancement, as loop diuretics are commonly used in heart failure patients to aid kidney function but can have adverse effects with long-term use.
Ian Crosbie, CEO of Sequana Medical, commented, "We are delighted with this publication highlighting the improved safety and efficacy of our proprietary DSR 2.0 vs dextrose-based approaches... 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."
DSR 2.0 vs. DSR 1.0
The published paper builds on previous studies, including those published in Circulation, demonstrating that DSR 1.0 increased sodium removal four-fold compared to standard peritoneal dialysis solutions. The current research details the development of an optimized solution for sodium and water removal. Specifically, previous human experiments showed that one liter of DSR 1.0 with a two-hour dwell removed an average of 4.5g of sodium with a net ultrafiltration volume of 700mL. In contrast, 0.5L of DSR 2.0 with a 24-hour dwell removed approximately 9g of sodium with a net ultrafiltration volume of 2,500mL.
alfapump System
Sequana Medical's other lead candidate is alfapump, a device designed for patients with fluid buildup in the abdomen. The alfapump system, already CE marked and in use in Europe for over a decade, automatically collects fluid and moves it to the bladder for elimination through urination. The system is currently under review by the FDA, with potential approval expected before the end of Q1 2025.
