- Data from GLP[i] animal studies demonstrate safety of second-generation DSR[ii] product (DSR 2.0)
- Data from Phase 1 study of DSR 2.0 in Mexico (CHIHUAHUA) and IND[iii] filing to US FDA expected in Q1 2023
- Planning to start MOJAVE, a US Phase 1/2a randomized controlled multi-center study of DSR 2.0, in Q2 2023
Ghent, Belgium – 08 February 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 the successful completion of its GLP animal studies, demonstrating the safety of its second-generation DSR product (DSR 2.0), following chronic exposure. These animal data, together with the data from the Phase 1 CHIHUAHUA study, are intended to support the US IND filing of DSR 2.0. FDA approval of the US IND will enable the Company to start MOJAVE, its randomized, controlled, multi-center Phase 1/2a US study of DSR 2.0, planned for Q2 2023.