Sequana Medical Secures Key U.S. Patent for DSR Heart Failure Therapy
Key Insights
Sequana Medical (search) received U.S. patent 12,496,384 B2 for its Direct Sodium Removal (DSR (search)) therapy, covering formulations and methods for treating heart failure and severe renal dysfunction.
The patent strengthens intellectual property protection for DSR (search)'s second-generation infusate used in the MOJAVE randomized controlled study, building on existing patents in the U.S., Europe, Japan, and China.
Clinical data from RED DESERT and SAHARA studies published in European Journal of Heart Failure showed DSR (search) eliminated congestion-related re-hospitalizations and reduced predicted one-year mortality by 75%.
Sequana Medical (search) NV announced the granting of U.S. patent number 12,496,384 B2 for its Direct Sodium Removal (DSR (search)) programme, a breakthrough therapy targeting cardiorenal syndrome and diuretic-resistant heart failure. The patent, entitled "Formulations and Methods for Direct sodium removal in patients having heart failure and/or severe renal dysfunction," covers the DSR infusate and its method of operation.
The patent specifically protects the use of a no or low sodium infusate administered to a patient's peritoneal cavity to directly remove sodium and fluid from the body, alleviating fluid overload in heart failure patients with residual renal function. This intellectual property builds upon existing granted DSR (search) patents in the U.S., Europe, Japan, and China.
Clinical Evidence Supports Breakthrough Potential
Data published in the European Journal of Heart Failure from Sequana Medical (search)'s RED DESERT and SAHARA studies demonstrate DSR (search)'s potential to break the negative feedback cycle of cardiorenal syndrome. Extensive analysis of patients in these studies showed benefits across multiple parameters: volume status improvement, normalized diuretic response with dramatically reduced loop diuretic dosing, improved kidney function, enhanced neurohormonal status and signaling, and better cardiovascular parameters.
Notably, patients treated with DSR (search) experienced no congestion-related re-hospitalizations, achieved a one-class improvement in their NYHA status, and showed a 75% reduction in their predicted one-year mortality based on the Seattle Heart Failure model.
MOJAVE Study Shows Promising Early Results
Initial data from the non-randomized cohort of the U.S. MOJAVE study support these findings. All three patients in this Phase 1/2a multi-center clinical study were successfully treated with DSR (search), resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements. Specifically, patients demonstrated a mean increase of 326% in six-hour urinary sodium excretion at three months follow-up versus baseline, alongside a 95% reduction in loop diuretics over the same period.
The independent Data Safety Monitoring Board has approved the start of the randomized MOJAVE cohort of up to 30 additional patients, though this phase is dependent on securing additional financing.
Addressing a Critical Clinical Challenge
Fluid overload, or congestion, represents a key clinical challenge in heart failure management. Current therapies have not been shown to improve patient outcomes in this complex indication, with loop diuretics actually exacerbating many core mechanisms underlying cardiorenal syndrome. The clinical burden is substantial, with U.S. heart failure-related hospitalization costs estimated at over $14 billion, and over 90% of these hospitalizations attributed to congestion. Approximately one in four patients are readmitted within 30 days of discharge due to current therapy limitations.
Ian Crosbie, Chief Executive Officer at Sequana Medical (search), stated: "We are very pleased with the granting of this additional US patent, which we believe provides significant additional protection for our DSR (search) programme. This patent builds upon our extensive pre-clinical and clinical experience of DSR, including the RED DESERT and SAHARA studies and strengthens the protection for our second generation DSR infusate."
Patent Portfolio Strengthened
The newly granted patent strengthens protection for Sequana Medical (search)'s second-generation DSR (search) infusate, which is the formulation being used in the U.S. MOJAVE randomized controlled study. This represents the company's most advanced DSR formulation, designed to deliver significant clinical benefits to clinicians and patients while providing commercial benefits to the company.
DSR (search) therapy remains in development and is not currently approved in any country. The safety and effectiveness of DSR therapy has not been established, though initial clinical data indicate the treatment is safe and well tolerated while restoring diuretic response and improving cardio-renal health.