Sequana Medical Announces Positive Interim Data From North American Pivotal alfapump® Study (POSEIDON)
Conference call with live webcast presentation today at 02:00 pm CET / 08:00 am EDT
GHENT, Belgium, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Sequana Medical NV (Euronext Brussels: SEQUA), an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces positive interim results from the first 13 patients in the Roll-In Cohort of the North American pivotal POSEIDON study of the alfapump for the treatment of recurrent or refractory ascites due to liver cirrhosis. These interim data show positive outcomes against all primary endpoints of the study1, as well as indications of clinically relevant improvements in quality of life measures.
Professor Florence Wong, University of Toronto, Hepatologist at Toronto General Hospital, Ontario, Canada and Principal Investigator for the POSEIDON study, commented: “I am delighted to see the first, positive, results of these roll-in patients. The dramatic reduction in the need for therapeutic paracentesis and improvement in quality of life is consistent with my long experience with the alfapump. The adverse events were as expected in this population of patients and easily controlled with the standard of care treatments. So if the results are replicated in all study patients, it would be an important improvement in the care for this poorly served patient population.”
POSEIDON is a single arm, open-label, within subject crossover study of the alfapump in patients with recurrent or refractory ascites due to liver cirrhosis in the U.S. and Canada. The study includes a “Pivotal Cohort” with up to 50 patients implanted with the alfapump for primary endpoint analysis and an additional “Roll-In Cohort” with up to 30 patients to ensure new centres are familiarised with the alfapump system before they enrol patients in the Pivotal Cohort.
The study is designed to demonstrate in Pivotal Cohort patients 1) a 50% reduction in average monthly frequency of therapeutic paracentesis (TP) post-alfapump implant versus pre-implant and that 2) at least 50% of patients will achieve a 50% reduction in the requirement for TP post-implant versus pre-implant. Paracentesis is the mainstay in chronic clinical management of refractory ascites but it is an invasive procedure, requiring frequent hospitalisations, severely impacting patients’ quality of life and provides only temporary benefit.
In this interim analysis, 13 patients from the Roll-In Cohort (underlying etiology: 61% alcohol, 23% non-alcoholic steatohepatitis (NASH), 8% hepatitis C and 8% mixed etiology) were implanted with the alfapump. Before enrolment, these patients required on average 3.4 TP per month. The mean reduction in the frequency of TP post-implant versus pre-implant was over 90%, with all patients having at least a 50% reduction in the average frequency of TP per month1.
Patient’s quality of life was assessed via established health-survey questionnaires. Results from SF36 (a general health quality survey) indicated clinically relevant improvements in the physical component score and improvement was seen in all SF36 subscales. Ascites Q, a questionnaire developed for patients with ascites also indicated clinically relevant improvement in patient’s quality of life and the improvement was seen in all subdomains of the survey. In both cases, the improvement was seen rapidly (within a month of implantation) and was persistent (6 months after implantation).
Based on these interim data, the safety profile of the alfapump is consistent with previously reported data. The adjudication process by the Clinical Events Committee (CEC) for two alfapump explants in respect of the primary safety outcome is still ongoing.
Ian Crosbie, Chief Executive Officer at Sequana Medical, added: “The substantial reduction in the need for therapeutic paracentesis, good safety profile and clinically relevant improvement in quality of life reported in this study so far is very encouraging. These data further validate the potential of alfapump as a much needed treatment option in this underserved patient population and is an important milestone towards achieving a future marketig application in the U.S. and Canada. The increasing prevalence of NASH-related cirrhosis in this market and the limitations of the current standard of care has been recognized in our FDA Breakthrough Device Designation for alfapump, which will allow us to bring this innovative technology to patients in need as quickly as possible.”
Interim data of the full Roll-In Cohort are expected in H1 2021 and primary endpoint read-out of the Pivotal Cohort is expected in Q1 2022. The POSEIDON study is intended to support a future marketing application of the alfapump in the U.S. and Canada, with an FDA submission expected in mid-2022.
1 Pre- and post-implant periods for this analysis of the Roll-In Cohort differ from those that will be used for the Pivotal Cohort analysis
Conference Call and Webcast
Sequana Medical will host a conference call with live webcast presentation today at 02:00 pm CET / 08:00 am EDT.
The webcast and conference call will be conducted in English and a replay will be available on Sequana Medical’s website shortly after.
For more information, please contact:
About the pivotal POSEIDON study
Pivotal Cohort patients will enter into a three month pre-implant observation period in which they will receive standard of care therapy (consisting of therapeutic paracentesis) before the alfapump is implanted. Patients from the Roll-In cohort will upon implementation of the inclusion/exclusion criteria, immediately be implanted with the alfapump. The primary effectiveness outcomes of the study include the proportion of patients with a 50% reduction in the overall average frequency of therapeutic paracentesis per month in the post-implant observation period (month four to month six after implantation) as compared to the pre-implant observation period. The primary safety endpoint is the rate of alfapump related re-interventions adjudicated by the Clinical Events Committee. Patients will be followed for up to two years for analysis of secondary outcome measurements including safety (device and/or procedure-related adverse events), quality of life (assessed by general SF36 as well as disease-specific Ascites Q questionnaires), patients’ nutritional status, health economics and overall survival. For more information about the study, please visit clinicaltrials.gov (NCT03973866).
About recurrent and refractory ascites
Sequana Medical’s alfapump is a fully-implanted, programmable, wireless, CE-marked device that automatically pumps ascites from the peritoneal cavity into the bladder, where the body eliminates the ascites naturally through urination. The potential of the alfapump to address the unmet medical need in patients with recurrent or refractory ascites has been demonstrated in multiple clinical studies showing a significant reduction in the need for large volume paracentesis and a significant improvement in patients’ quality of life.
About Sequana Medical
In the U.S., the company's key growth market, the alfapump has been granted breakthrough device designation by the FDA. The North American pivotal study (POSEIDON) in recurrent or refractory ascites due to liver cirrhosis is currently underway, and is intended to support a future marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 800 alfapump systems have been implanted to date. Building on its proven alfapump platform, Sequana Medical is developing the alfapump DSR, a breakthrough, proprietary approach to fluid overload due to heart failure. Clinical proof-of-concept was achieved in a first-in-human single dose DSR study and further supported by strong interim safety and efficacy results from the ongoing repeated dose alfapump DSR study (RED DESERT) in heart failure patients.
Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.
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