Wednesday, February 08, 2023
Sequana Medical NV, 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.
The GLP studies were conducted on 30 healthy mice and 18 healthy sheep. Each animal study comprised of three study groups which included one control group using standard peritoneal dialysis (PD) solution and two test groups using Sequana Medical’s proprietary DSR 2.0 product. The test groups consisted of one group being given the anticipated maximum standard dose and one group being given double of the maximum dose. The mice were exposed for 30 days, resembling their average life time, and the sheep were exposed for up to 45 days.
The purpose of these GLP studies was to evaluate the chronic exposure of DSR 2.0 on animal health and tissue of peritoneum, kidneys, omentum, and peritoneal cavity. Data from both studies reported that no difference in systemic and local toxic effects were observed in animals treated repeatedly with DSR 2.0, compared to animals in the control group, concluding that DSR 2.0 had consistent safety with the standard PD solution.
Oliver Gödje, Chief Medical Officer at Sequana Medical, commented: “We are pleased to see these positive animal data of our second-generation DSR product, which is designed to deliver therapeutic and safety benefits over the first-generation DSR product. We have previously reported impressive clinical results from the SAHARA study with DSR 1.0 as a potential disease-modifying heart failure therapy, and we look forward to commencing MOJAVE, the first randomized controlled multi-center study in the US using DSR 2.0.”