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.

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.”

On track to start MOJAVE with DSR 2.0 in Q2 2023

The Company is progressing the development of its proprietary DSR 2.0 product, a sodium-free dextrose / icodextrin solution expected to have an improved therapeutic and favourable safety profile, and robust intellectual property protection. Two ongoing Phase 1 interventional, single-centre, single-arm studies, one in Canada (YUKON) and one in Mexico (CHIHUAHUA), are evaluating the safety, tolerability and efficacy of DSR 2.0 and are expected to each enroll up to ten stable peritoneal dialysis patients to receive a single treatment of DSR 2.0, administered through their peritoneal dialysis catheter. The choice of peritoneal dialysis patients is driven by their pre-existing peritoneal dialysis catheter. Data from the GLP animal and Phase 1 CHIHUAHUA studies are intended to support the filing of the US IND, planned for Q1 2023.

Following several initial discussions with the FDA, MOJAVE, a randomized controlled Phase 1/2a US study of DSR 2.0, is on track to start in Q2 2023, assuming FDA approval of the US IND application. The intention is to enrol 30 diuretic-resistant chronic heart failure patients with persistent congestion, with 20 patients randomized to DSR 2.0 administered via a peritoneal catheter on top of usual care for congestive heart failure (CHF) for up to four weeks and ten patients randomized to intravenous loop diuretic treatment as part of maximized usual care for CHF alone. Following four weeks of treatment, there will be a three-month safety follow-up period. Prior to enrolment of these 30 patients, the intention is for three additional patients to be enrolled in a non-randomized safety cohort and to receive DSR 2.0 administered via a peritoneal catheter on top of CHF usual care for up to four weeks. Progression to the enrolment of the 30 randomized patients will be dependent upon DSMB[iv] approval following their review of the initial three patients. More details on the final study design will be announced following the FDA approval of the US IND application. Interim data of MOJAVE are expected in H2 2023 followed by top-line results in H2 2024.