Michael Barbella, Managing Editor05.12.23
Sequana Medical NV has further strengthened its intellectual property portfolio for its DSR (Direct Sodium Removal) program with two new patents.
Chinese regulatory authorities recently granted the company a key composition of matter patent, and U.S. officials awarded Sequana Medical a patent on the method of operation. “As the evidence for DSR’s disease-modifying effect in heart failure grows, we continue to build a strong patent portfolio for our DSR program and the patent allowed in China is an important international reinforcement of that," Sequana Medical CEO Ian Crosbie said. "Cardiovascular disease is the leading cause of healthcare burden in China with 4.5 million people suffering from heart failure.1 The Chinese market offers huge potential for DSR where we believe it represents a compelling treatment option in this large and growing heart failure market."
Chinese patent application number 201880045801.6, 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 regions such as Australia, Canada and Japan. It protects the use of a sodium-free or low-sodium infusate that is administered into a patient’s peritoneal cavity to directly remove sodium, and thereby fluid from the body to alleviate fluid overload in heart failure patients with residual renal function.
U.S. patent number 11,602,583 B2 covers the expansion of the method of operation for Sequana Medical’s 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 U.S. patent granted gives further flexibility to use implantable pump systems, such as its alfapump, to provide patients with long-term support.
Sequana Medical has filed 16 patents for its DSR program, of which six have been granted, covering a broad range of aspects, both for the method of operation and composition of matter.
“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," Crosbie stated. "Use of DSR therapy with an implantable pump system such as ouralfapump 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 United States and plans to begin a U.S. randomized controlled Phase 1/2a clinical trial in Q2 2023.
alfapump and DSR are Sequana Medical's proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems. The company has reported positive primary endpoint data from the North American pivotal POSEIDON trial of the alfapump in recurrent or refractory ascites due to liver cirrhosis, enabling the filing of a pre-market approval (PMA) application with the U.S. Food and Drug Administration, planned for the second half of 2023. Having delivered clinical proof-of-concept for DSR as a disease-modifying drug program for the treatment of heart failure, the company is planning to begin MOJAVE, a U.S. multi-centered randomized controlled Phase 1/2a clinical trial of DSR 2.0, in the second quarter this year.
The alfapump system is currently not approved in the United States or Canada. In the United States and Canada, the alfapumpsystem is currently under clinical investigation (POSEIDON Trial) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis
Sequana Medical NV develops solutions for treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. These patients can have up to 15 liters of extra fluid in their bodies, causing major medical issues including increased mortality, repeated hospitalizations, severe pain, difficult breathing and restricted mobility that severely impacts daily life. Although diuretics are standard of care, the problem is that in many patients they are no longer effective and / or tolerable. There are limited effective treatment options for these patients, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is listed on Euronext Brussels and headquartered in Ghent, Belgium.
Reference
1 Weiwei et al., European Heart Journal Supplements (2016), European Society of Cardiology
Chinese regulatory authorities recently granted the company a key composition of matter patent, and U.S. officials awarded Sequana Medical a patent on the method of operation. “As the evidence for DSR’s disease-modifying effect in heart failure grows, we continue to build a strong patent portfolio for our DSR program and the patent allowed in China is an important international reinforcement of that," Sequana Medical CEO Ian Crosbie said. "Cardiovascular disease is the leading cause of healthcare burden in China with 4.5 million people suffering from heart failure.1 The Chinese market offers huge potential for DSR where we believe it represents a compelling treatment option in this large and growing heart failure market."
Chinese patent application number 201880045801.6, 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 regions such as Australia, Canada and Japan. It protects the use of a sodium-free or low-sodium infusate that is administered into a patient’s peritoneal cavity to directly remove sodium, and thereby fluid from the body to alleviate fluid overload in heart failure patients with residual renal function.
U.S. patent number 11,602,583 B2 covers the expansion of the method of operation for Sequana Medical’s 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 U.S. patent granted gives further flexibility to use implantable pump systems, such as its alfapump, to provide patients with long-term support.
Sequana Medical has filed 16 patents for its DSR program, of which six have been granted, covering a broad range of aspects, both for the method of operation and composition of matter.
“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," Crosbie stated. "Use of DSR therapy with an implantable pump system such as ouralfapump 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 United States and plans to begin a U.S. randomized controlled Phase 1/2a clinical trial in Q2 2023.
alfapump and DSR are Sequana Medical's proprietary platforms that work with the body to treat diuretic-resistant fluid overload, delivering major clinical and quality of life benefits for patients and reducing costs for healthcare systems. The company has reported positive primary endpoint data from the North American pivotal POSEIDON trial of the alfapump in recurrent or refractory ascites due to liver cirrhosis, enabling the filing of a pre-market approval (PMA) application with the U.S. Food and Drug Administration, planned for the second half of 2023. Having delivered clinical proof-of-concept for DSR as a disease-modifying drug program for the treatment of heart failure, the company is planning to begin MOJAVE, a U.S. multi-centered randomized controlled Phase 1/2a clinical trial of DSR 2.0, in the second quarter this year.
The alfapump system is currently not approved in the United States or Canada. In the United States and Canada, the alfapumpsystem is currently under clinical investigation (POSEIDON Trial) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis
Sequana Medical NV develops solutions for treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. These patients can have up to 15 liters of extra fluid in their bodies, causing major medical issues including increased mortality, repeated hospitalizations, severe pain, difficult breathing and restricted mobility that severely impacts daily life. Although diuretics are standard of care, the problem is that in many patients they are no longer effective and / or tolerable. There are limited effective treatment options for these patients, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is listed on Euronext Brussels and headquartered in Ghent, Belgium.
Reference
1 Weiwei et al., European Heart Journal Supplements (2016), European Society of Cardiology