Sequana Medical NV, a pioneer in the treatment of drug-resistant fluid overload in liver disease and heart failure, 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:
