Sequana Medical's DSR programme receives additional patents from China & US

Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure, and cancer, has announced a significant expansion of its intellectual property portfolio for its DSR (Direct Sodium Removal) programme. A key composition of matter patent was granted in China, and a method of operation patent was granted in the United States. On March 7, 2023, Chinese patent application number 201880045801.6 was granted.

This critical patent, titled "Direct sodium removal method, solution, and apparatus to reduce fluid overload in heart failure patients," has already been granted in the United States and Europe and is pending in other countries including Australia, Canada, and Japan. It protects the use of a sodium-free or low-sodium infusate administered into a patient's peritoneal cavity to directly remove sodium and thus fluid from the body in heart failure patients with residual renal function to alleviate fluid overload.

On March 14, 2023, Sequana Medical received US patent number 11,602,583 B2, which covers the expansion of the method of operation for DSR therapy using an implantable pump system. While the company's current focus is on short-term DSR therapy using a peritoneal catheter, the additional US patent granted gives the company more flexibility to use implantable pump systems, such as its alfapump, to provide long-term support to patients. Sequana Medical has filed 16 patents for its DSR programme, 6 of which have been granted, covering a wide range of aspects, both for method of operation and matter composition.

"As the evidence for DSR's disease-modifying effect in heart failure grows, we continue to build a strong patent portfolio for our DSR programme, and the patent allowed in China is an important international reinforcement of that," said Ian Crosbie, chief executive officer of Sequana Medical. With 4.5 million people suffering from heart failure, cardiovascular disease is the leading cause of healthcare burden in China. DSR has enormous potential in the Chinese market, where we believe it is a compelling treatment option in this large and growing heart failure market. “Following the long-lasting clinical benefits observed in our RED DESERT and SAHARA proof-of-concept studies, we are focusing on Short Term DSR therapy using a peritoneal catheter. Use of DSR therapy with an implantable pump system such as our alfapump could be of great relevance in particular populations of congestive heart failure patients requiring regular DSR therapy.

Today’s announcement gives this approach further strong patent protection.” Sequana Medical considers its proprietary DSR to be a disease modifying therapy for congestive heart failure. Fluid accumulation in heart failure patients is caused by the retention of too much sodium. The DSR drug-based approach directly tackles this key clinical problem of sodium overload, and works in partnership with the kidneys to safely and rapidly eliminate the excess fluid. Complementary to existing heart failure therapies, clinical proof-of-concept studies using the Company’s first-generation DSR product (DSR 1.0) have shown that DSR can i) safely, effectively and rapidly eliminate fluid overload in heart failure patients, ii) improve the health of the heart and preserve renal function, and iii) restore the ability of the kidney to manage the fluid and sodium naturally, resulting in a large and long-lasting reduction in the need for diuretic drugs.

In DSR treated patients, there have been no congestion-related re-hospitalizations during the study follow-up period, all patients improved their NYHA status by at least one class and the clinical benefits observed in the clinical studies resulted in a 75% reduction in predicted one-year mortality of patients pre- vs. post-intensive DSR therapy based on the Seattle Heart Failure Model. The Company is currently preparing an IND application for its second-generation DSR product (DSR 2.0) in the US and plans to begin a US randomized controlled Phase 1/2a clinical trial in Q2 2023. Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer.