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Sequana Medical - Positive data in non-randomised MOJAVE cohort

Sequana Medical has announced interim results from all three patients comprising the non-randomised cohort of its MOJAVE US Phase I/IIa study evaluating its second-generation Direct Sodium Removal (DSR) product, DSR 2.0, in diuretic-resistant chronic heart failure (CHF) patients with persistent congestion. Consistent with data already reported in October from the cohort’s first two patients, the third patient has also shown beneficial treatment effects from the DSR therapy. To date, the results indicate DSR 2.0 is safe and well tolerated and all three patients restored and maintained euvolemia without the need of loop diuretics and showed improved cardiorenal status post-treatment, as demonstrated through different measures. All three patients are in their three-month safety follow-up period and, in early Q124, the study’s independent Data and Safety Monitoring Board (DSMB) is expected to review their data. As no clinically relevant changes in serum sodium levels, serious adverse events or hospitalisations have occurred, we are confident that the DMSB will permit the progression of MOJAVE to the randomised cohort phase, which is designed to recruit an additional 30 patients.