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MOJAVE – US Phase 1/2a study of DSR 2.0 for treatment of heart failure Previously reported strong data maintained after three-months follow-up: Diuretic response remained nearly normalized, with a mean increase of 326% in six-hour urinary sodium excretion vs baselineAll three patients remained on no or low dose loop diuretics, with a reduction of at least 95% vs baseline Randomized cohort of up to 30 additional patients planned to commence following US market approval of the alfapump® Ghent, Belgium – 25 March 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the 'Company' or 'Sequana Medical'), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces final three-month follow-up data from all three patients in the non-randomized cohort of MOJAVE, the Company’s US Phase 1/2a study of DSR 2.0 for treatment of patients with diuretic-resistant heart failure, confirming the dramatic and durable improvement in their diuretic response and virtual elimination of loop diuretic requirements.
MOJAVE–美国DSR 2.0治疗心力衰竭的1/2a期研究先前报告了三个月随访后维持的强劲数据:利尿剂反应几乎恢复正常,六小时尿钠排泄量平均比基线增加326%所有三名患者仍服用无剂量或低剂量袢利尿剂,与基线随机队列相比,至少减少了95%,该队列计划在美国市场批准比利时根特的alfapump®根特之后开始-2024年3月25日-Sequana Medical NV(布鲁塞尔泛欧交易所:SEQUA)(“公司”或“Sequana Medical”),肝病,心脏病液体超负荷治疗的先驱失败与癌症,今天宣布了莫哈韦非随机队列中所有三名患者的最终三个月随访数据,该公司的DSR 2.0美国1/2a期研究用于治疗利尿剂抵抗性心力衰竭患者,证实其利尿反应的显着和持久的改善以及环路利尿剂需求的虚拟消除。
These final data support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. Dr. Oliver Gödje, Chief Medical Officer of Sequana Medical, commented: “These final data from the first three patients in the MOJAVE cohort are highly encouraging and together with the positive data from our RED DESERT and SAHARA proof-of-concept studies, indicate the potential for our DSR therapy as a promising treatment for diuretic-resistance and cardiorenal syndrome in heart failure.” Ian Crosbie, Chief Executive Officer of Sequana Medical, added: “We continue to be excited about our DSR program and its potential to transform the treatment of diuretic resistance and and cardiorenal syndrome in heart failure.Unlike loop diuretics w.
这些最终数据支持DSR打破心肾综合征恶性循环的作用机制。Sequana Medical首席医疗官Oliver Gödje博士评论道:“这些来自莫哈韦队列前三名患者的最终数据非常令人鼓舞,再加上我们的红沙漠和撒哈拉概念验证研究的积极数据,表明我们的DSR治疗有可能成为心力衰竭利尿抵抗和心肾综合征的有希望的治疗方法。”Sequana Medical首席执行官Ian Crosbie补充道:“我们继续对DSR计划及其改变心力衰竭利尿抵抗和心肾综合征治疗的潜力感到兴奋。与袢利尿剂不同。