Sequana Medical has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) on 31 March 2023 for its second-generation DSR product (DSR 2.0) for the treatment of congestive heart failure.
Clearance of the IND will pave the way for the Company to initiate its randomised controlled Phase 1/2a MOJAVE study in the US, planned for Q2 2023.
The IND application includes data from the previously reported GLP animal and Phase 1 CHIHUAHUA studies supporting the safety and tolerability profile of Sequana Medical’s DSR 2.0 product, as well as the strong safety and efficacy data reported from RED DESERT and SAHARA proof-of-concept studies with its first-generation DSR product (DSR 1.0). Additionally, the application also contains manufacturing information of DSR 2.0 and an outline of the MOJAVE study design.
There are an estimated 200,000 US heart failure patients suffering from diuretic-resistant congestion
Oliver Gödje, Chief Medical Officer of Sequana Medical, commented: “Today’s announcement is an important milestone for our DSR program. There are an estimated 200,000 US heart failure patients suffering from diuretic-resistant congestion that requires repeated hospitalisation at an estimated cost of $14bn a year, and therefore an urgent need for new therapies such as DSR to alleviate this burden and improve patients’ lives. We are very excited to build upon the exciting results from our RED DESERT and SAHARA studies and bring our second generation product, DSR 2.0 into the clinic in the US. We look forward to reporting data from the first US patients later this year.”
The final study design of the randomised controlled Phase 1/2a MOJAVE study in the US will be communicated upon approval by the FDA and Ethics Committees. Following several initial discussions with the FDA, the intention is to enroll 30 diuretic-resistant chronic heart failure patients with persistent congestion. Of these, 20 randomised patients will receive DSR 2.0 administered via a peritoneal catheter on top of usual care for congestive heart failure for up to four weeks and ten randomised patients will receive intravenous loop diuretic treatment as part of maximised usual care for congestive heart failure 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 patients to be enrolled in a non-randomised safety cohort and to receive DSR 2.0 administered via a peritoneal catheter on top of congestive heart failure usual care for up to four weeks. Advancing to the enrolment of the 30 randomised patients is anticipated to be dependent upon DSMB approval following their review of the initial three patients.