Belgian pharmaceutical company Sequana Medical has enrolled the first patient in its MOJAVE Phase I/IIa study of DSR 2.0, a product intended to treat diuretic-resistant chronic heart failure patients with persistent congestion.
The randomised study will be carried out in the US to assess the efficacy and safety of the second-generation DSR 2.0 product.
Three patients enrolled in a non-randomised cohort of the study will initially receive DSR 2.0, followed by up to 30 additional patients in the randomised cohort.
Progression to the randomised cohort will depend on the approval of the non-randomised cohort data by the Data and Safety Monitoring Board (DSMB).
Up to 20 of the 30 patients will receive DSR 2.0 through a PD catheter in addition to optimised usual care for congestive heart failure for up to four weeks.
The remaining ten will be treated with intravenous loop diuretics alone as part of maximised usual care for congestive heart failure.
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After four weeks of treatment with DSR 2.0, Sequana will carry out a three-month safety follow-up.
The rate of adverse and serious adverse events, as well as the improvement in diuretic response from baseline until the end of the treatment period, are the trial’s primary and secondary safety and efficacy endpoints.
Exploratory endpoints will measure changes in weight, creatinine, natriuretic peptides and New York Heart Association functional class, as well as the number of heart failure-related rehospitalisations.
Sequana Medical chief medical officer Oliver Gödje said: “We are excited to commence this important study that builds on the strong clinical evidence already reported for our DSR programme.
“With our MOJAVE study, we seek to confirm the strong safety and efficacy data observed in our RED DESERT and SAHARA studies and look forward to reporting data from the first three patients by end of the year.”