Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announces positive top-line results from SAHARA, the Phase 2a study using its first-generation DSR (Direct Sodium Removal) 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.

To evaluate the safety, tolerability and efficacy of the Company’s second-generation DSR product (DSR 2.0), a single-arm, open-label, Phase 1 study has been initiated in Canada (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 MOJAVE. Data from YUKON, together with CHIHUAHUA, a further Phase 1 study in Mexico intended to support the US IND filing of DSR 2.0, planned for Q1 2023. These replace the previously planned SAHARA extension study with DSR 2.0. Approval of the US IND will enable the Company to start MOJAVE, its randomized controlled multi-center Phase 1/2a US study of DSR 2.0, planned for H1 2023.

Dr. Jeffrey Testani, Associate Professor at Yale University and Heart Failure Scientific Advisor to Sequana Medical, commented: “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. 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.”

Dr. 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 US using DSR 2.0.”

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