An extensive phase 1 clinical trial evaluates the safety of treatment among peritoneal patients.
Sequana Medical – a company focused on treating fluid overload in liver disease, heart failure and cancer – has announced positive results from its phase 1 CHIHUAHUA clinical trial. The study is a single-center, single-arm, single-dose trial incorporating DSR 2.0 candidates.
The research was conducted among ten stable peritoneal dialysis patients, who each received a single treatment of Sequana Medical’s proprietary DSR 2.0 product – administered through their pre-existing peritoneal dialysis catheter, during a 24-hour period.
The aim of the study was to evaluate the tolerability and safety profile of DSR 2.0, in addition to establishing dosing dynamics.
It emerged that DSR 2.0 was generally safe and well-tolerated, with no serious adverse events or discontinuations due to adverse events. None of the patients presented a clinically relevant change in serum sodium levels or progressive hyponatremia – providing further proof of safety.
Oliver Gödje, chief medical officer of Sequana Medical, reflected: “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 Investigational New Drug application with the US Food and Drug Administration for MOJAVE, our US randomised controlled phase 1/2a clinical trial, planned to start in Q2 2023.”
He added: “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.”
Meanwhile, Sequana Medical is continuing to progress with the development of its proprietary DSR 2.0 product – a sodium-free dextrose and icodextrin solution – by boosting its therapeutic and safety profile.