Sequana Medical has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) for its second-generation DSR product (DSR 2.0) for the treatment of congestive heart failure.
Fluid accumulation in heart failure patients is caused by the retention of too much sodium. The DSR drug-based approach works in partnership with the kidneys to safely and rapidly eliminate the excess fluid.
Clearance of the IND will pave the way for the company to initiate a randomised controlled Phase I/IIa MOJAVE study in the US, planned for Q2 2023.
The IND application includes data from the previously reported GLP animal and Phase I CHIHUAHUA studies supporting the safety and tolerability profile of DSR 2.0, as well as the strong safety and efficacy data reported from RED DESERT and SAHARA proof-of-concept studies with its first-generation DSR product (DSR 1.0).
Oliver Gödje, Chief Medical Officer of Sequana Medical, commented: “There are an estimated 200,000 US heart failure patients suffering from diuretic-resistant congestion that requires repeated hospitalisation at an estimated cost of $14bn a year, and therefore an urgent need for new therapies such as DSR to alleviate this burden and improve patients’ lives. We look forward to reporting data from the first US patients later this year.”
The final study design of the randomised controlled Phase I/IIa MOJAVE study in the US will be communicated upon approval by the FDA and Ethics Committees. Following several initial discussions with the FDA, the intention is to enrol 30 diuretic-resistant chronic heart failure patients with persistent congestion.