Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or Sequana Medical), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces positive interim results from six patients in SAHARA DESERT, the safety and feasibility study of alfapump DSR (Direct Sodium Removal) in heart failure patients with persistent congestion.

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We are extremely pleased with these interim results from SAHARA DESERT which, for the first time, indicate the ability of repeated DSR therapy to safely, effectively and rapidly eliminate persistent congestion in decompensated heart failure patients. Just as we showed in RED DESERT, we are able to achieve this, together with a major improvement in patients’ diuretic-response. It is promising to see the improved cardio-renal status of these patients compared to the status expected for patients undergoing volume removal. We look forward to the completion of enrolment to report on top-line data and the planned commencement of MOJAVE DESERT, our first U.S. DSR study, in H2 2022. The long-term follow-up data from our RED DESERT patients is very encouraging, indicating the sustained improvement in diuretic response as demonstrated by a clear reduction in the need for loop diuretics. This further indicates how powerful and versatile our alfapump DSR platform is and how it can address clear unmet medical needs within this large and growing patient population.”

Strong interim results from SAHARA DESERT

All six patients evaluated for the interim analysis had severe heart failure at baseline (mean left ventricle ejection fraction percentage in low 20’s and mean NT-proBNP of > 6,000 pg/ml), with persistent congestion despite being on high dose loop diuretics (mean furosemide equivalent dose of approx. 250 mg per day). Out of the six patients in the interim analysis, one patient had completed phase 2 of the study, three patients were in phase 2 and two patients were in phase 1.

After intensive alfapump DSR therapy in phase 1, patients had a mean weight loss of approx. 6kg or 7% of their body weight vs. baseline and all patients achieved euvolemia without the need of any loop diuretics. These interim data also showed a near normalisation of diuretic response with six-hour excretion of sodium more than doubling vs. baseline, as well as an improvement in NT-proBNP, a key cardiac function parameter, with a mean reduction of more than 30% vs. baseline. The mean eGFR (estimated Glomerular Filtration Rate) and creatinine after completion of phase 1 (active fluid removal) was similar to baseline, which is remarkable since worsening in kidney function during significant volume removal is the expectation in severely ill diuretic-resistant patients such as these. Patients who completed phase 1 are at less than 10% of their baseline loop diuretic dose (n=4, mean time post end of phase 1 is three months).

Serial alfapump DSR therapy was safe and well tolerated with few adverse events and there were no clinically significant changes in serum sodium levels or other electrolytes observed in these six patients after intensive DSR therapy.

To date, nine patients have been enrolled at two centers in SAHARA DESERT and implanted with the alfapump DSR system, of which six patients were evaluated for this interim analysis and two more patients just started study treatment. One additional patient was enrolled but died due to a cardiac arrest three days after study initiation. The death was deemed by the site unrelated to the study therapy, procedure or device; the Data Monitoring Committee assessed the event as possibly related to the study therapy but not related to the procedure or device. Patient enrollment continues as planned and reporting of top-line data is expected in H2 2022.

Dr. Jeffrey Testani, Associate Professor at Yale University and Heart Failure Scientific Advisor of Sequana Medical, commented: “These interim results are highly encouraging and could potentially provide a course of therapy for severely ill diuretic-resistant heart failure patients with persistent congestion where alternative treatment options are currently exceedingly limited. We are looking forward to completing the study and presenting the top-line data of all patients by the end of next year.”

Dr. Oliver Gödje, Chief Medical Officer at Sequana Medical, added: “SAHARA DESERT represents the continuing development of our alfapump DSR therapy, and the interim results are a further indication of its unique capabilities. Our RED DESERT study showed that alfapump DSR could improve the diuretic response and cardio-renal status in patients with diuretic-resistant heart failure. SAHARA DESERT is building on these strong results as we focus on our anticipated patient population, those heart failure patients with persistent congestion, for whom oral diuretics is no longer effective at preventing fluid overload, a patient population particularly difficult to manage by healthcare professionals and where alfapump DSR could offer a real change in the treatment paradigm.”

Long-term follow-up of RED DESERT patients demonstrates sustained improvement of diuretic response

In May 2021, Sequana Medical reported strong top-line results of RED DESERT (NCT04116034) in seven euvolemic heart failure patients on high dose diuretics. Following the six-week study, patients continued to be followed for up to 19 months. One patient died nine months after the end of the study (unrelated to DSR therapy). All patients had a reduction in their oral loop diuretic dose ranging from 40% to 96% at their last visit within the follow-up period (9-19 months after last DSR treatment in the study), showing a significant durability to the improvement in diuretic responsiveness following alfapump DSR therapy.

Strong progress in development of proprietary DSR Infusate 2.0

A key element of Sequana Medical’s DSR programme is the development of the proprietary DSR Infusate 2.0, to deliver an infusate with a superior therapeutic profile as well as a high margin recurring revenue stream to accompany alfapump sales. Chemistry, Manufacturing and Controls (CMC) of DSR Infusate 2.0 is progressing well and pre-clinical development work is on track. The MOJAVE DESERT study, the first U.S. study of short-term DSR therapy in chronic heart failure patients with persistent congestion, is planned to start in H2 2022.