Sequana Medical’s IND application to begin the phase 1/2a MOJAVE study with DSR 2.0 to treat congestive heart failure has been approved by the US FDA.

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The US Food and Drug Administration (FDA) has approved Sequana Medical NV’s investigational new drug (IND) application for its second-generation DSR product (DSR 2.0) for the treatment of congestive heart failure. Sequana Medical NV is a pioneer in the treatment of fluid overload in liver disease, heart failure, and cancer. This makes it possible for the business to start its planned Q2 2023 US randomised controlled phase 1/2a MOJAVE research. Sequana Medical’s Oliver Gödje, the company’s chief medical officer, said: “We are pleased to receive clearance of the IND for our DSR 2.0 product and are prepared to start the MOJAVE research in US patients with congestive heart failure as soon as possible. We are currently concentrating on enrolling our first patient, which we anticipate will happen in the second quarter of 2023. By the end of the year, we hope to present data from the three patients in the non-randomized group.

According to Ian Crosbie, CEO of Sequana Medical, “There is an urgent need for new therapies that can safely and effectively relieve congestion, lower repeated hospitalisations, and improve clinical outcomes for the estimated 200,000 diuretic-resistant congestive heart failure patients in the US. We think that our DSR therapy has the potential to be a disease-modifying heart failure therapy in light of the outstanding safety and efficacy evidence provided from our RED DESERT and SAHARA proof-of-concept studies. In the US, MOJAVE is a randomised controlled phase 1/2a trial intended to assess the safety and effectiveness of DSR 2.0 in patients with persistent congestion who are diuretic-resistant chronic heart failure.

Following the Ethics Committee’s approval, the study will begin with a non-randomized cohort of three qualified patients who will receive DSR 2.0 in addition to their regular congestive heart failure treatment for up to four weeks, followed by a three-month safety follow-up period. DSR 2.0 will be administered via a peritoneal dialysis (PD) catheter. After reviewing the data from the non-randomized cohort, the Data and Safety Monitoring Board (DSMB) must give its permission before the up to 30 additional patients in the randomised cohort can move forward. The randomised cohort consists of up to ten randomised patients treated with intravenous loop diuretics alone as part of maximised usual care for congestive heart failure and up to twenty randomised patients treated with DSR 2.0, administered via a PD catheter, on top of usual care for congestive heart failure for up to four weeks. The four-week therapy phase is followed by a three-month safety follow-up period.

The rate of adverse and serious adverse events as well as the improvement in the diuretic response (measured as a six-hour urine sodium output) from baseline through the completion of the treatment period are primary and secondary safety and effectiveness objectives. Change in weight (volume status), creatinine (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 are a few exploratory endpoints that were measured from baseline through the end of the treatment period.

Sequana Medical views its exclusive DSR treatment for congestive heart failure as a disease-modifying medicine. Patients with heart failure who retain too much sodium develop fluid buildup. The DSR drug-based strategy directly addresses the major clinical issue of salt overload and collaborates with the kidneys to quickly and safely clear the extra fluid. Clinical proof-of-concept trials employing the company’s first-generation DSR product (DSR 1.0) have demonstrated that DSR can be used as a supplement to current heart failure medications. Eliminate fluid retention in heart failure patients quickly, safely, and effectively. Improve heart health and renal function. Restore the kidney’s natural ability to regulate fluid and sodium levels. Significantly reduce the need for diuretic medications. All patients who received DSR therapy saw at least a one-class improvement in their NYHA status, and the clinical benefits seen in the clinical studies led to a 75% decrease in the predicted one-year mortality of patients prior to vs. following intensive DSR therapy based on the Seattle Heart Failure Model. Additionally, there were no congestion-related re-hospitalizations in DSR-treated patients during the study follow-up period.

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