Sequana Medical shares positive results from phase 1 clinical trial

pharmafile | March 1, 2023 | News story | Research and Development  

Sequana Medical has shared positive results from its phase 1 trial, CHIHUAHUA, assessing the safety and tolerability of a single dose of a second-generation DSR product (DSR 2.0) to treat congestive heart failure. The trial showed that the new product was safe and well-tolerated, also showing a positive dosing profile.

The company are expected to file for FDA approval by the end of the first quarter of 2023.

The phase 1 trial included ten stable peritoneal dialysis patients, who received a single treatment of the DSR 2.0 product, administered through their existing dialysis catheters over a 24-hour period.

Generally, the drug was safe and well-tolerated, with no serious adverse events recorded, also no patients showed any clinically relevant changes in serum sodium levels or progressive hyponatremia, which additionally proves the treatment’s safety.

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 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.”


Betsy Goodfellow

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