Sequana Medical NV, an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, announces that the first patient has been enrolled in the SAHARA DESERT study. Interim results are expected at the end of 2021 and top-line results in H2 2022.
Building on the strong results from RED DESERT(1), SAHARA DESERT is conducted in heart failure patients with residual congestion for whom oral diuretics are no longer effective at preventing fluid overload. The study will enrol 20 patients and will evaluate the ability of alfapump DSR therapy to eliminate residual congestion, restore correct fluid status (euvolemia) and improve cardio-renal condition for up to 22 weeks.
Dr Oliver Gödje, Chief Medical Officer at Sequana Medical, commented: “We have been bold in developing our proprietary DSR (Direct Sodium Removal) therapy and the recent RED DESERT study results lead us to believe that DSR therapy, as long-term and short-term treatment, could be a breakthrough for the large number of heart failure patients with diuretic-resistant congestion. The SAHARA DESERT study will now assess alfapump DSR therapy in decompensated heart failure patients, our intended patient population, for whom there are limited alternative treatment options.”
Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “As pioneers in the development of treatment options for diuretic-resistant fluid overload, we are very excited to start SAHARA DESERT. This study will enhance our understanding of how rapidly intensive DSR therapy can remove persistent congestion, improve diuretic response and cardio-renal function and how long these effects last whilst on maintenance DSR therapy. The removal of persistent congestion and improvement of cardio-renal function is a clear unmet clinical need in this large and growing patient population and we look forward to reporting interim results before year-end.”