Sequana Medical Begins Enrolling First Patient in MOJAVE Study, Investigating DSR® 2.0 for the Treatment of Congestive Heart Failure in the United States
Monday, July 10, 2023
Sequana Medical NV (Euronext Brussels: SEQUA), a pioneering company in the treatment of fluid overload in liver disease, heart failure, and cancer, has announced the enrollment of the first patient in its MOJAVE study. MOJAVE is a randomized controlled Phase 1/2a study conducted in the US, aiming to assess the safety and efficacy of Sequana Medical's second-generation DSR product, DSR 2.0, in diuretic-resistant chronic heart failure patients with persistent congestion.
The study will commence with a non-randomized cohort of three patients who will receive treatment with DSR 2.0. The progression to the randomized cohort, potentially including up to an additional 30 patients, is subject to approval from the Data and Safety Monitoring Board (DSMB) after reviewing the data from the non-randomized cohort, which is expected in the fourth quarter of 2023.
Congestive heart failure is the leading cause of hospitalizations in patients over 65 years old in the US, with approximately one million admissions annually, primarily due to symptoms of fluid overload. A significant proportion of these patients experience diuretic resistance, leading to persistent congestion upon discharge, and a considerable number of them get readmitted within 30 days. There is a critical need for new therapies that can effectively eliminate congestion, improve clinical outcomes, and potentially modify the course of heart failure. Sequana Medical believes that DSR has the potential to be a disease-modifying therapy for these patients.
The non-randomized cohort of the MOJAVE study will consist of three eligible patients who will receive DSR 2.0 treatment administered through a peritoneal dialysis (PD) catheter, in addition to optimized usual care for congestive heart failure. The treatment period will last up to four weeks, followed by a three-month safety follow-up period.
The study's primary and secondary safety and efficacy endpoints include assessing the incidence of adverse and serious adverse events, as well as measuring the improvement in diuretic response (measured as a six-hour urine sodium output) from baseline to the end of the treatment period. Exploratory endpoints measured during the treatment period include changes in weight (indicating volume status), creatinine levels (a marker of renal function), natriuretic peptides (a marker of heart failure), New York Heart Association (NYHA) functional class, and the number of heart failure-related rehospitalizations.