Sequana Medical announces positive results from CHIHUAHUA, Phase 1 clinical trial of second-generation DSR product for congestive heart failure

• Phase 1 clinical trial (CHIHUAHUA) demonstrates that single dose of second-generation DSR product (DSR 2.0) is safe and well-tolerated, and indicates a compelling dosing profile

• On track to file IND (i) application to US FDA in Q1 2023

• Start of MOJAVE, a US multi-center randomized controlled Phase 1/2a clinical trial of DSR 2.0, planned for Q2 2023

This Phase 1 trial was conducted in ten stable peritoneal dialysis patients, who received a single treatment of Sequana Medical’s proprietary DSR 2.0 product, administered via their pre-existing peritoneal dialysis catheter, over a 24-hour dwell period. The purpose of the trial was to evaluate the safety and tolerability profile of DSR 2.0, as well as to understand the dosing dynamics of DSR 2.0.

DSR 2.0 was generally safe and well-tolerated, with no serious adverse events or discontinuations due to adverse events. No patient showed a clinically relevant change in serum sodium levels or progressive hyponatremia, a further proof of safety of DSR 2.0. On average, a total of approximately 3L of fluid was removed per patient including 9g of sodium following a single treatment with 0.5L DSR 2.0 and a 24-hour dwell period.

Oliver Gödje, Chief Medical Officer of Sequana Medical, commented: “The results of this study are really encouraging and, together with the positive safety data from the GLP (ii) studies reported earlier this month, enable the filing of our IND application with the US FDA for MOJAVE, our US randomized controlled Phase 1/2a clinical trial, planned to start in Q2 2023.
In addition to positive safety and tolerability findings, with no serious adverse events or discontinuations, the amount of fluid and sodium removed following a single treatment is an indication of the effectiveness of DSR 2.0 as a potential treatment for patients with congestive heart failure.”

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 that is expected to have an improved therapeutic and favourable safety profile, and robust intellectual property protection. Data from the GLP animal studies (iii) and Phase 1 CHIHUAHUA study are intended to support the filing of the US IND application, planned for Q1 2023.

Following several initial discussions with the FDA, MOJAVE, a US multi-center randomized controlled Phase 1/2a clinical trial of DSR 2.0, is on track to start in Q2 2023, assuming FDA approval of the IND application. The intention is to enrol 30 diuretic-resistant chronic heart failure patients with persistent congestion. Of these, 20 randomized patients will receive 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 randomized patients will receive 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 is anticipated to be dependent upon DSMB (iv) approval following their review of the initial three patients. More details on the final trial 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.

(i) IND: Investigational New Drug
(ii) GLP: Good Laboratory Practices
(iii) Data reported in press release of 8 February 2023
(iv) DSMB: Data and Safety Monitoring Board