Sequana Medical announces positive results from second interim analysis of North American pivotal alfapump® study (POSEIDON)

The Company also announces that based on an analysis of attrition between study enrolment and alfapump implantation, it is anticipated that approximately 10 additional patients will need to be enrolled in the Pivotal Cohort. Among other factors, COVID-19-related delays in elective surgery resulted in some enrolled patients in the Pivotal Cohort no longer meeting the inclusion criteria at the time of planned implantation. As a consequence, patient recruitment is now expected to complete in Q3 2021 (instead of Q2 2021) and reporting of the primary endpoint in Q3 2022 (instead of Q2 2022). Filing of the Pre-Market Approval (PMA) to the U.S. FDA remains planned for H2 2022.

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “I’m delighted to see the results from this larger cohort of Roll-In patients reaffirming the previous positive efficacy results of the alfapump and providing longer-term evidence of the reduction in therapeutic paracentesis and continued improvements in quality of life. While we anticipate the need to enroll additional patients due to higher attrition in the pre-implant observation period, this is a reflection of how the condition of these patients continues to deteriorate, and underlines how important alfapump can be to these patients. The last patients are expected to be enrolled over the next quarter, and we are looking forward to the rapid completion of POSEIDON.”

Professor Florence Wong, University of Toronto, Hepatologist at Toronto General Hospital, Ontario, Canada and Principal Investigator for the POSEIDON study, commented: “Ascites imposes a heavy burden and devastating impact on patients’ quality of life. These interim results further demonstrate that the alfapump could provide great benefit to patients and help limit their visits to the hospital for paracentesis. The safety data are in line with expectations and reassuring for the potential of the alfapump as a long-term treatment in this fragile patient population. I look forward to continuing to study the alfapump and generating further data to reinforce its potential to address this significant unmet medical need.”

Positive interim data of 26 patients from Roll-In Cohort

In this second interim analysis, 26 patients from the Roll-In Cohort (underlying etiology: 50% alcohol, 23% non-alcoholic steatohepatitis (NASH), 4% NASH-alcohol, 4% hepatitis C and 19% other/mixed etiology) were implanted with the alfapump. Before enrolment, these patients required on average 3.8 Therapeutic Paracenteses (TP) per month, an indication that North American patients seem to have more TP per month compared to Europe. Data from this Roll-In Cohort substantially exceed the primary endpoints as defined for the Pivotal Cohort in the study, demonstrating a mean reduction of over 90% in the frequency of TP post-implant versus baseline and all patients having at least a 50% reduction in the mean frequency of TP per monthi.

The new quality of life data, assessed via established health-survey questionnaires SF36 (a general health quality survey) and Ascites Q (a questionnaire developed for patients with ascites) confirm the rapid positive impact of the alfapump on patient’s quality of life. Both, the mean physical component score of SF36 and the mean score of Ascites Q, show a clinically important improvement (exceeding the threshold for Minimal Clinically Important Difference) from baseline to 6 months post-implantation and the improvement in quality of life measures was maintained for up to 12 months post-implantation (n=6 patients at 12 months).

Safety profile is in line with expectations with no unanticipated adverse device effects (UADEiii) during the course of the study. Three out of the 26 Roll-In patients experienced a composite primary safety event as adjudicated by the Clinical Events Committee (CEC), including one patient who died due to an implant procedure-related event and the other two patients having the alfapump explanted, one due to wound dehiscence and the other due to persistent hematuria after a car accident.

Primary endpoint data of Pivotal Cohort expected in Q3 2022

The POSEIDON study design includes a three-month observation period between study enrolment and alfapump implantation for patients in the Pivotal Cohort. A detailed review of study enrolment, including an analysis of attrition between study enrolment and planned alfapump implantation has identified a higher rate of attrition than forecast when the study was planned. The cause of this includes the number of patients whose alfapump implantation was delayed for COVID-related matters and subsequently failed to meet re-evaluation of study inclusion / exclusion criteria prior to implantation, likely due to disease progression. The review concluded that approximately 10 additional patients will need to be enrolled in the Pivotal Cohort in order to implant up to 50 patients with the alfapump following the three-month observation period. Completion of patient enrolment is now expected in Q3 2021 instead of Q2 2021, with planned reporting of the primary endpoint in Q3 2022.