November 30, 2023 — Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that all three patients from the non-randomized cohort of the MOJAVE study were successfully treated with DSR 2.0. Data from the third patient show similar beneficial effects of DSR therapy as reported previously in the first two patientsii.
Dr. Oliver Gödje, Chief Medical Officer of Sequana Medical, commented: “We are delighted to see the timely execution of the non-randomized cohort and the encouraging outcomes of our DSR therapy in these first three US patients with diuretic-resistant heart failure. These data strengthen our confidence in a positive independent DSMB review scheduled for early Q1 2024, and we look foward to the commencement of the randomized cohort in up to 30 US patients. This critical next phase will facilitate a comparison between our innovative DSR therapy and conventional loop diuretics, reaffirming our commitment to providing transformative solutions for patients with high unmet medical need.”
Positive data from non-randomized cohort of MOJAVE study
All three patients treated in the non-randomized cohort of the MOJAVE study had heart failure with preserved ejection fraction (HFpEF) and severe diuretic resistance at baseline (mean furosemide equivalent dose of 1,227 mg per day). At the start of the study treatment period, loop diuretics were withheld, and patients were treated with DSR 2.0 up to daily for four weeks.
During the four-week DSR treatment period, all three patients maintained euvolemia without the need of loop diuretics and showed improved cardiorenal status post-treatment. Their diuretic responseiii nearly normalized with a mean increase of 324% in their six-hour urinary sodium excretion post-treatment vs baseline. These interim data also show a broad improvement in their kidney function with a a mean improvement in eGFRiv of 47% and blood urea nitrogenv of 57% post-treatment vs baseline. Since patients had HFpEF, their NT-proBNPvi levels were within normal ranges at baseline and were maintained post-treatment, indicating that their stable cardiovascular status was preserved.
The need for loop diuretics was dramatically reduced or even completely eliminated following completion of the four-week DSR treatment period (see table below), which the Company believes is a demonstration of the durable improvement in cardio-renal health of the patient and supports DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. In addition, none of the patients needed to be hospitalized for congestion since the start of the study.
No. of weeks after last DSR therapy
Reduction in furosemide equivalent dose vs. baseline
To date, no clinically relevant changes in serum sodium levels or progressive hyponatremia were observed and no serious adverse events occurred, indicating that DSR 2.0 was safe and well tolerated in these first three US patients.
All three patients are currently in the three-month safety follow-up period and their data will be reviewed by an independent Data and Safety Monitoring Board (DSMB) planned in early Q1 2024 to approve the start of the randomized controlled cohort of up to a further 30 patients.
For more information: www.sequanamedical.com
i DSMB: Data Safety Monitoring Board
ii Initial data reported in Press release of 18 October 2023
iii Diuretic response assessed by 6-hour excretion of sodium after IV administration of 40mg furosemide
iv eGFR: estimated Glomerular Filtration Rate, a measure of kidney function
v Blood urea nitrogen is a waste product normally cleared by the kidneys
vi NT-proBNP: N-terminal pro B-type natriuretic peptide, a key cardiac function parameter
vii NYHA: New York Heart Association classification (data collected outside study protocols of RED DESERT and SAHARA)