Sequana Medical announces FDA clearance of IND application for DSR® 2.0 for treatment of congestive heart failure
- MOJAVE study on track to start in Q2 2023 as planned, with initial data by year-end
- Randomized, controlled study in US seeking to confirm strong efficacy data seen in RED DESERT and SAHARA studies
- DSR well positioned as disease-modifying heart failure therapy
Ghent, Belgium – 02 May 2023 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its second-generation DSR product (DSR 2.0) for the treatment of congestive heart failure. This enables the Company to initiate its randomized controlled Phase 1/2a MOJAVE study in the US, in Q2 2023 as planned.