Sequana Medical announces positive data from non-randomized cohort in US Phase 1/2a MOJAVE study of DSR® 2.0 for treatment of heart failure

• Data from all three patients in non-randomized cohort treated with DSR 2.0 indicate

  • safe and effective maintenance of euvolemia without the need for loop diuretics,

  • considerable benefit in cardiorenal status and

  • dramatic improvement in diuretic response and loop diuretic requirements up to 11 weeks post DSR treatment

• DSMB (i) review planned for early Q1 2024 to approve start of randomized controlled cohort of up to 30 US patients

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 response (iii) 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 eGFR (iv) of 47% and blood urea nitrogen (v) of 57% post-treatment vs baseline. Since patients had HFpEF, their NT-proBNP (vi) 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.

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.

(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