Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease and heart failure, today announces the completion of enrollment in its Phase 2a SAHARA proof-of-concept study using its first-generation DSR product (“DSR 1.0”) as treatment for congestive heart failure. Sequana Medical intends to extend SAHARA to treat  a small number of patients with its proprietary second-generation DSR product (“DSR 2.0”) to support the US IND filing, expected by year end.

The Company has conducted two proof-of-concept studies, the RED DESERT study in euvolemic heart failure patients and the SAHARA study in decompensated heart failure patients, demonstrating that intensive DSR therapy with DSR 1.0 delivers compelling and durable clinical improvements in diuretic-resistant heart failure patients, including safe, rapid and effective decongestion, dramatic improvement in cardio-renal status and restoration of diuretic responsiveness. As a result of the strong, durable clinical signals observed, the Company will focus the heart failure development program on Short Term DSR with its proprietary DSR 2.0 administered with a peritoneal catheter.

Ian Crosbie, Chief Executive Officer of Sequana Medical, said: “We are very encouraged by the results from our DSR program and consider Short Term DSR to be a disease-modifying drug therapy for this large and very difficult-to-treat patient population. Based on what we have learned from RED DESERT and SAHARA, we will focus on Short Term DSR using our proprietary DSR 2.0. With just three to four weeks of DSR treatment, we believe that we can bring patients important clinical benefits lasting up to a year and progress this potential breakthrough therapy to patients in need as efficiently as possible.”

Dr. Oliver Gödje, Chief Medical Officer at Sequana Medical, added: “We and our advisors are very impressed by the results and see DSR therapy as a treatment for heart failure that is complementary to other therapies.  As cardiologists, we struggle to remove congestion from patients with diuretic resistance, which is the primary driver of morbidity and hospitalization in heart failure. DSR therapy tackles the key clinical need of sodium overload in patients in whom loop diuretics are no longer effective. The patients treated with DSR therapy in our studies have not been re-hospitalized for congestion-related heart failure problems during their study follow-up period and the clinical outcomes resulted in a substantial increase in predicted survival using the Seattle Heart Failure Model. We are now preparing for a US IND filing of our DSR 2.0 by year end to start MOJAVE, our Phase 1b/2a US study.”

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