The study aims to:
- Evaluate the safety of alfapump DSR in patients with heart failure
- Assess the feasibility of alfapump DSR to remove excess sodium and fluid from the body
- Explore the potential impact of DSR therapy to restore response to diuretics
Ghent, BELGIUM – 7 January 2020 – Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces that the first patient has been enrolled in the first-in-human repeated dose study of alfapump DSR (Direct Sodium Removal) for the treatment of diuretic-resistant heart failure patients.
The prospective, single-arm, repeated dose study named RED DESERT is expected to include up to 10 heart failure patients, who are on high dose diuretics, across two centres in Belgium and Georgia. The primary safety endpoints include the rate of device, procedure and/or therapy-related serious adverse events after two and six weeks. The secondary endpoints include the feasibility of alfapump DSR to remove excess sodium and fluid from the body, thereby eliminating the need for daily high dose diuretics during the six-week treatment period. Additional exploratory endpoints to measure the potential impact of DSR therapy to restore response to diuretics will be evaluated through week six. Results are expected to be reported in Q2 and Q3 2020.
Volume overload is the driver of more than 90% of the one million heart failure hospitalisations in the U.S. each year (which in total account for $13 billion in costs). Rehospitalisation is common and approximately 24% of these patients are re-admitted within 30 days of discharge. Sequana Medical’s innovative DSR therapy removes sodium from the body which in turn eliminates the associated fluid to restore sodium concentration, resulting in sustained fluid removal. Positive results from a first-in-human single dose DSR proof-of-concept study demonstrating that DSR therapy can result in the removal of large quantities of sodium and fluid in a safe and tolerable manner were presented at Heart Failure 2019 in Athens and TCT 2019 in San Francisco. alfapump DSR leverages the proven alfapump platform to deliver a fully implanted and automatic system for chronic outpatient DSR therapy.
“The start of RED DESERT is an important step in the development of alfapump DSR as a potential novel therapy for patients suffering from volume overload due to heart failure,” commented Ian Crosbie, CEO of Sequana Medical. “This study will provide us further insights regarding the safety and dosing of our breakthrough DSR therapy and the feasibility of alfapump DSR to provide a novel treatment alternative to this large and poorly served patient group. We look forward to reporting initial interim results in Q2 2020 and presenting the final results in Q3 2020.”
“A large percentage of heart failure patients are poorly controlled with conventional diuretics and there remains an urgent need for effective therapies for these patients,” added Dr. Jeffrey Testani, Associate professor at Yale University. “Sequana Medical’s alfapump DSR system has the potential to deliver a convenient and effective non-diuretic treatment option in patients with heart failure. We have previously reported promising signals from a single dose study with DSR. I look forward to the results of this repeated dose study which will inform on the potential value of DSR in chronic heart failure patients.”
“I am excited about the first patient enrolment in RED DESERT,” added Dr. Jozef Bartunek, Cardiologist at Cardiovascular Center, OLV Hospital Aalst, Belgium and Principal Investigator of the study. “I look forward to reporting on the clinical potential of alfapump DSR in vulnerable heart failure patients who are not well controlled on standard diuretic regimen.”