The open-label Phase I/II MOJAVE trial (NCT05965934) is designed to evaluate the DRS therapy in patients with congestive heart failure who are resistant to loop diuretic treatment. Image Credit: zentradyi3ell / Shutterstock.

Belgium-based Sequana Medical has released data from the Phase I/II MOJAVE study in the US, which is evaluating its direct sodium removal (DRS) therapy in patients with congestive heart failure.

The results showed the diuretic response in patients with diuretic-resistant heart failure improved and treatment with DRS therapy can also eliminate the need to use loop diuretics in these patients.

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DRS therapy causes sodium removal to the peritoneal cavity through diffusion. To achieve this, a ‘sodium-free’ DRS solution is administered into the abdomen, and due to a diffusion gradient, the sodium is extracted into the DRS solution, which is removed from the body via the bloodstream and/or urination.

Loop diuretics, commonly prescribed for heart failure patients, perform a similar function of reducing fluid overload.

The open-label Phase I/II MOJAVE trial (NCT05965934) is designed to evaluate the DRS therapy in patients with congestive heart failure who are resistant to loop diuretic treatment. The analysis of the three patients in the non-randomised cohort of the study showed a normalised mean increase of 324% in their six-hour urinary sodium excretion, compared to the baseline, following four-week DSR treatment.

Three months following the last DSR treatment, the three patients showed a reduction in furosemide equivalent dose of 97%, 100% and 95%, respectively, compared to the baseline. Two serious adverse events, one short-term hypertension and one non-ST-elevation myocardial infarction, were observed. The company was quick to add that the events “occurred during the three-month safety follow-up period and are often seen in this very sick patient population”.

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Sequana plans to enrol up to 30 patients in the randomised phase of the MOJAVE trial, 20 in the treatment group and ten in the control group. which would be treated with loop diuretics. The enrolment for the randomised phase is expected in Q3 2024, following the expected approval of Sequana’s alfapump therapy. 

The alfapump implantable device is currently under review by the US Food and Drug Administration (FDA) as a treatment for liver ascites – fluid buildup in the abdomen. The application is supported by the data from the POSEIDON study (NCT03973866), which met its primary effectiveness and safety endpoints. Sequana expects FDA approval by Q3 2024.