Sequana Medical NV, an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, has announced positive interim results from the first five patients enrolled in an important new study.
Background
The RED DESERT study is evaluating repeated dose treatment of Sequana’s alfapump DSR (Direct Sodium Removal) in diuretic-resistant heart failure patients.
Five heart failure patients on high dose diuretics underwent up to six weeks of alfapump DSR treatment. The alfapump DSR implant procedure and repeated dosing of DSR therapy were well tolerated in all patients with few adverse events.
There were no clinically significant changes in serum sodium levels or progressive hyponatremia (low concentration of sodium in the blood) in these patients after repeated DSR dosing. The results also show that during the course of the six-week therapy, no loop diuretics were required, demonstrating the ability of the alfapump DSR system to effectively remove sodium and fluid from these patients. Moreover, in the majority of patients, reduced doses of DSR therapy could be utilised and / or some DSR doses could be omitted while maintaining stable to lower weight and natriuretic peptides compared to baseline.
The RED DESERT study will enrol up to five additional patients, with top-line data expected in H1 2021.
Company comments
Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We are hugely excited by these results from the first five RED DESERT patients and believe it is the first time ever that fluid balance in heart failure patients has been managed using repeated dose DSR therapy without the need for diuretics. These data support the underlying principle of DSR that after we remove sodium, the body will step in to quickly and accurately remove the free water necessary to restore the serum sodium concentration. Not only does the data suggest that by using alfapump DSR, we can manage the fluid and sodium balance of these patients, but also the restoration of diuretic response opens up further potential opportunities such as renal failure and haemodialysis. Following the allowance of our key patents in both the U.S. and Europe, we are confident that we will continue to lead the way in the use of alfapump DSR for the management of volume overload in a range of indications.”
Investigator comments
“Diuretic-resistance is a nearly ubiquitous problem in heart failure patients resulting in untreated volume overload and high rates of hospitalisation. The results from these first five patients in the RED DESERT study are very promising and point to the potential use of the alfapump DSR in this difficult to treat patient population that has a clear unmet need,” said Dr. Jozef Bartunek, Interventional Cardiologist at Onze-Lieve-Vrouw Hospital in Aalst (Belgium) and Principal Investigator of the RED DESERT study.
“The durable improvement in diuretic responsiveness is particularly interesting. With additional confirmation of these encouraging results through continued study, I believe alfapump DSR has the potential to become a new therapy for the management of volume overload and diuretic resistance,” added Dr. Jeffrey Testani, Associate Professor at Yale University and Heart Failure Scientific Advisor of Sequana Medical.
Source; Sequana Medical NV
published: October 22, 2020 in: Clinical Studies/Trials, News, Specialty