Sequana Medical NV (Euronext Brussels: SEQUA), a commercial stage medical device company focused on the development of innovative treatment solutions for the management of liver disease, heart failure, malignant ascites and other fluid imbalance disorders, will announce the results of the first-in-human single dose DSR (Direct Sodium Removal) proof-of-concept study for volume overload in heart failure following the late-breaking presentation at the Heart Failure 2019 congress on 27 May 2019.

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About the first-in-human single dose DSR proof-of-concept study

The study (clinicaltrials.gov NCT03801226) was conducted by Dr. Testani at Yale University, in up to 20 patients receiving peritoneal dialysis who underwent randomization and crossover to DSR infusate (a sodium-free solution) or standard peritoneal dialysis (PD) solution. One litre of either DSR infusate or standard PD solution was infused into the peritoneum and left to dwell for two hours before being removed. The patient repeated the procedure with the alternate solution one week later. The primary endpoints include safety and tolerability, defined as completion of the two-hour dwell without significant discomfort or adverse events. The secondary efficacy endpoint of the study is the difference in sodium removal between DSR infusate and standard PD solution.

About DSR therapy

Sequana Medical’s proprietary DSR therapy is under development and is a novel approach to the management of volume overload in heart failure, a major clinical problem and a significant burden on healthcare systems. The body’s response to heart failure causes sodium levels to increase, which in turn leads to the body retaining more fluid. Sequana Medical’s innovative DSR therapy involves the removal of sodium via diffusion from the body into the peritoneal cavity by administering a sodium-free solution (“the DSR infusate”) into the abdomen. The DSR infusate and the extracted sodium are then removed, resulting in the elimination of sodium from the body. The body responds by eliminating the associated fluid via osmotic ultrafiltration (the movement of water, together with sodium, from the bloodstream to the peritoneal cavity) and/or urination.

The impact of administering a sodium-free solution to the peritoneal cavity, and the resulting sodium and fluid removal, was evaluated in a preclinical study with 15 pigs, of which five had experimentally induced heart failure. The study demonstrated that DSR therapy is capable of removing large quantities of fluid and sodium whilst having a negligible impact on the sodium concentration in the bloodstream, indicating the potential of this therapeutic approach.

About Volume Overload in Heart Failure

Volume overload in heart failure is a major clinical problem. There are an estimated 6.5 million adults in the U.S. suffering from heart failure and this number is expected to grow to 8.0 million by 2030. There are approximately one million hospitalisations for heart failure annually in the U.S. and 90% are due to symptoms of volume overload. The treatment options are severely limited in those patients for whom diuretic therapy is no longer effective. This limitation is evident from the 24% hospital re-admission rate at 30 days from discharge. The estimated cost of heart failure-related hospitalisations in the U.S. is $13 billion per year.