DSMB Approves Randomized Phase for Sequana Medical's MOJAVE Heart Failure Trial

Sequana Medical NV, a company specializing in treating fluid overload in conditions such as liver disease, heart failure, and cancer, has reported positive safety outcomes for its DSR 2.0 treatment in a recent study. The independent Data and Safety Monitoring Board (DSMB) has given the green light for the next phase of the MOJAVE study, a U.S.-based clinical trial focused on patients with heart failure who are resistant to diuretic medications.

The non-randomized cohort of the MOJAVE study involved three patients who received DSR 2.0 treatment for a duration of four weeks. The treatment was found to significantly improve their diuretic response and renal function, with a substantial reduction in the requirement for loop diuretics, which was maintained for up to almost four months post-treatment. The patients showed an average increase of 324% in urinary sodium excretion and notable improvements in their estimated glomerular filtration rate (eGFR) and blood urea nitrogen levels.

The randomized controlled cohort of the study is set to include up to 30 additional patients across various centers in the U.S. The treatment group will consist of up to 20 patients who will receive DSR 2.0 in addition to their optimized standard care for congestive heart failure. A control group of up to ten patients will be treated with intravenous loop diuretics as part of their maximized standard care. Following the final DSR treatment, patients will be monitored for safety for a three-month period. The study aims to further validate the safety and efficacy of DSR 2.0 in managing fluid overload in heart failure patients.

Dr. Oliver Gödje, Sequana Medical's Chief Medical Officer, expressed optimism regarding the study's progress and the potential of DSR as a transformative therapy for heart failure. He stated that the company is eager to enroll the first patient in the randomized cohort and looks forward to sharing interim data later in the year.

The MOJAVE study builds upon previous studies, RED DESERT and SAHARA, which demonstrated the benefits of DSR therapy in improving volume status, diuretic response, kidney function, neurohormonal status, and cardiovascular parameters in heart failure patients. The ongoing study is expected to provide further evidence supporting the role of DSR in addressing cardiorenal syndrome, a complex clinical challenge in heart failure characterized by the interplay of heart and kidney dysfunction.

Sequana Medical is committed to developing innovative solutions for patients with diuretic-resistant fluid overload, offering alternatives to standard diuretic treatments that often become ineffective or exacerbate the problem. The company's alfapump® and DSR® platforms are designed to work with the body to manage fluid overload, aiming to improve clinical outcomes and quality of life for patients while reducing healthcare costs.

The company has submitted a Premarket Approval (PMA) application for the alfapump to the U.S. FDA, following positive results from the POSEIDON study in patients with liver cirrhosis and recurrent or refractory ascites. Sequana Medical continues to advance its research and development efforts, striving to provide effective treatment options for the growing population of patients with fluid overload conditions.