Sequana Medical, a company treating fluid overload in liver disease, heart failure and cancer, has announced positive results from its Phase I single-centre, single-arm, single-dose trial (CHIHUAHUA) with its second-generation DSR product (DSR 2.0).
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.
This Phase I trial was conducted in ten stable peritoneal dialysis patients, who received a single treatment of DSR 2.0, administered via their pre-existing peritoneal dialysis catheter, over a 24-hour dwell period.
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 studies reported earlier this month, enable the filing of our IND application with the US FDA for MOJAVE, our US randomised controlled Phase I/IIa 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.”