{"id":362823,"date":"2023-11-28T19:00:00","date_gmt":"2023-11-29T00:00:00","guid":{"rendered":"https:\/\/platohealth.ai\/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-biospace\/"},"modified":"2023-11-29T06:30:22","modified_gmt":"2023-11-29T11:30:22","slug":"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-biospace","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/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-biospace\/","title":{"rendered":"Sequana Medical announces positive data from non-randomized cohort in US Phase 1\/2a MOJAVE study of DSR\u00ae 2.0 for treatment of heart failure | BioSpace","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
PRESS RELEASE<\/strong> Ghent, Belgium \u2013 29 November 2023\u2013 Sequana Medical NV<\/a> (Euronext Brussels: SEQUA) <\/strong>(the “Company<\/strong>” or “Sequana<\/strong>Medical<\/strong>“), 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<\/sup>.<\/p>\n Dr. Oliver G\u00f6dje, Chief Medical Officer of Sequana Medical, commented:<\/em><\/strong> \u201cWe 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.\u201d<\/em><\/p>\n Positive data from non-randomized cohort of MOJAVE study<\/u><\/p>\n 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.<\/p>\n 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<\/sup> 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<\/sup> of 47% and blood urea nitrogenv<\/sup> of 57% post-treatment vs baseline. Since patients had HFpEF, their NT-proBNPvi<\/sup> levels were within normal ranges at baseline and were maintained post-treatment, indicating that their stable cardiovascular status was preserved.<\/p>\n 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\u2019s 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.<\/p>\n
REGULATED INFORMATION \u2013 INSIDE INFORMATION<\/strong>
29 November 2023, 07:00 am CET<\/u><\/strong><\/p>\n\n
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