Sequana Medical has had some very positive top-line results from a phase 2a study, that the company says reinforces its view that direct sodium removal (DSR) is a potential disease modifying heart failure therapy.
The study called SAHARA was testing its first-generation DSR product, DSR 1.0.
Data from ten evaluable diuretic-resistant heart failure patients with persistent congestion who have completed the 16-week follow-up period after intensive DSR therapy confirm the previously reported strong interim data showing important and long-lasting clinical benefits.
Sequana Medical studies
To evaluate the safety, tolerability and efficacy of Sequana Medical’s second-generation DSR product (DSR 2.0), a single-arm, open-label, phase 1 study has been initiated in Canada called YUKON with up to 10 patients on peritoneal dialysis receiving a single treatment of DSR 2.0.
The first patient has been dosed successfully and the results of this study will be used to determine dosing of DSR 2.0 in the study called MOJAVE. Data from YUKON, together with CHIHUAHUA, a further phase 1 study in Mexico intended to support the U.S. investigational new drug (IND) filing of DSR 2.0, planned for the first quarter of 2023. These replace the previously planned SAHARA extension study with DSR 2.0.
Jeffrey Testani, associate professor at Yale University and heart failure scientific advisor to Sequana Medical, said: “Congestion is a key driver of heart failure and remains the leading cause of morbidity and hospitalization in this large and growing patient population. Diuretic-resistance is widespread and the usual therapeutic approach is just adding more diuretics, further worsening the underlying issues.
Diuretic resistance
“There are no therapies that seek to correct the cardio-renal pathophysiology causing the diuretic-resistance. The SAHARA results are highly encouraging and indicate the potential for DSR therapy to deliver clinically meaningful decongestion and durable improvements in cardio-renal function and thus diuretic response.”
Approval of the U.S. IND will enable the company to start MOJAVE, its randomized controled multi-center phase 1/2a U.S. study of DSR 2.0, planned for the first half of 2023.
Oliver Gödje, chief medical officer of Sequana Medical, added: “These results are very positive and reinforce our view that DSR is a potential disease-modifying heart failure therapy. We are excited to have the first patient dosed with DSR 2.0 and we are confident that this second-generation product will deliver important therapeutic and safety benefits. I would like to thank the investigators, patients and care personnel involved in both SAHARA and YUKON, and we look forward to commencing MOJAVE, the first randomized controlled multi-center study in the U.S. using DSR 2.0.”