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Belgium-based Sequana Medical has announced data from the US Phase I/II MOJAVE trial evaluating direct sodium removal (DRS) therapy for patients with congestive heart failure.
The results showed that diuretic response improved in patients with diuretic-resistant heart failure and that treatment with DRS therapy could also eliminate the need for loop diuretics in these patients.
DRS therapy causes the removal of sodium into the peritoneal cavity by diffusion. To accomplish this, a “sodium-free” DRS solution is administered into the abdomen, and a diffusion gradient extracts sodium into his DRS solution, which is then removed from the body through the bloodstream and/or urination.
Loop diuretics, commonly prescribed to heart failure patients, perform a similar function of reducing fluid overload.
The open-label Phase I/II MOJAVE trial (NCT05965934) was designed to evaluate DRS therapy in patients with congestive heart failure refractory to loop diuretic therapy. Analysis of three patients in the study’s nonrandomized cohort showed that after 4 weeks of DSR treatment, 6-hour urinary sodium excretion increased by a normalized mean of 324% compared to baseline. It was done.
Three months after the last DSR treatment, three patients showed a 97%, 100%, and 95% reduction in furosemide equivalent dose compared to baseline, respectively. Two serious adverse events were observed, one short-term hypertension and one non-ST-segment elevation myocardial infarction. The company quickly added that these events “occurred during the three-month safety follow-up period and are common in this critically ill patient population.”
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Sequana plans to enroll up to 30 patients in the randomization phase of the MOJAVE trial, with 20 expected to be in the treatment arm and 10 in the control arm. It will be treated with loop diuretics. With approval of Sequana’s alpha pump therapy expected, enrollment in the randomization phase is expected in Q3 2024.
The alfapump implantable device is currently under review by the U.S. Food and Drug Administration (FDA) as a treatment for hepatic ascites, a buildup of fluid in the abdomen. This application is supported by data from his POSEIDON study (NCT03973866), which met primary efficacy and safety endpoints. Sequana expects FDA approval by the third quarter of 2024.
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