Sequana Medical Announces FDA Approval to Expand Patient Recruitment in North American Pivotal Alfapump® Study (POSEIDON)

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PRESS RELEASE
REGULATED INFORMATION – INTERNAL INFORMATION
4 October 2021, 07h00 CET

  • Completion the number of patients expected before the end of the year

  • Preading the end point rimary due in Q4 2022

  • 59 the patients already recruited in the pivot cohort

Ghent, Belgic4 October 2021 Sequana Medical NV (Euronext Brussels: SEQUA, the “Company”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces that it has received Food and Drug Administration (FDA) approval for United States to expand the number of patients enrolled to 70 (an increase of 10) in the Pivotal Cohort of POSEIDON, the North American Pivotal Study of alfapump for the treatment of recurrent or refractory ascites due to cirrhosis of the liver. This extension of patient recruitment was requested by Sequana Medical to compensate for the higher attrition rate between study recruitment and alfaimplantation of the pump in the pivot cohort, with the objective of reaching 50 patients implanted with the alfapump.

To date, 59 patients have been included in the pivot cohort. The company expects patient enrollment to be completed by the end of the year with the primary endpoint reading in Q4 2022, in time for FDA regulatory submission in mid-2023.

Ian Crosbie, Managing Director of Sequana Medical, said: “We welcome the FDA’s approval to expand patient recruitment into POSEIDON and look forward to announcing the completion of recruitment. We will now resume our efforts to enroll these additional patients, after having had to suspend them pending this approval. Provisional data from POSEIDON produced strong results that indicate the potential for alfapump to provide an effective treatment that can significantly improve the quality of life of patients with recurrent or refractory hepatic ascites. We will continue to work diligently to bring the alfaone step closer to the growing number of patients who need a 21st century for this terrible disease. “

For more information please contact:

Sequana Medical
Lies Vanneste
Investor Relations Director
Phone: +32 498 05 35 79
E-mail: [email protected]

LifeSci Advisors
Guillaume de Renterghem
Phone: +41 76 735 01 31
E-mail: [email protected]

About the POSEIDON study

POSEIDON is a single-arm, open-label study with crossover subjects on the alfapump in patients with recurrent or refractory ascites due to cirrhosis of the liver and is conducted in approximately 20 centers in the United States and Canada. Patients are enrolled in the pivot cohort, entering the pre-implant observation period, allowing up to 50 patients to be implanted with the alfapump for the analysis of the primary endpoint. The study allows up to 35 patients to be enrolled in an integration cohort, in order to ensure that the centers have experience of alfaimplantation of the pump before enrolling patients in the pivot cohort. Patients in the pivot cohort enter a three-month pre-implant observation period during which they receive standard treatment (consisting of therapeutic paracentesis) prior to alfathe pump is implanted. Patients in the Roll-In cohort are immediately implanted with the alfapump.

A detailed review of first semester 2021 enrollment, including an analysis of attrition between enrollment and forecast alfaimplantation of the pump, identified a higher attrition rate than expected when planning the study. The cause was a number of patients whose alfaimplantation of the pump was delayed due to COVID-related issues and subsequently did not meet criteria for re-evaluation of study inclusion / exclusion criteria prior to implantation, likely due to progression of disease. The review concluded that approximately 10 additional patients should be recruited into the pivotal cohort in order to implant up to 50 patients with the alfaafter the three-month observation period, leading the Company to submit a protocol amendment to the FDA to expand patient recruitment.

The main measures for evaluating the effectiveness of the study include the proportion of patients with a 50% reduction in the overall mean frequency of therapeutic paracentesis per month during the post-implant observation period (from the fourth at the sixth month after implantation) compared to the pre-implantation period observation period. The primary endpoint of safety is the rate of alfapump-related reinterventions as judged by the Clinical Events Committee. Patients will be followed up to two years for analysis of secondary outcome measures, including safety (adverse events related to the device and / or procedure), quality of life (assessed by general SF36 as well as disease-specific ascites Q questionnaires), nutritional status, health economics and overall survival. For more information about the study, please visit clinicaltrials.gov (NCT03973866).

In July 2021, the Company reported the second positive interim analysis of the POSEIDON study. Data from 26 patients in the Roll-In cohort reconfirmed positive results against all primary endpoints1 and demonstrated (i) a greater than 90% reduction in the mean frequency of therapeutic paracentesis (PT) from baseline, (ii) all patients having at least a 50% reduction in mean frequency of PT per month from baseline, (iii) clinically significant improvement in quality of life maintained up to 12 months after implantation and (iv) safety profile as expected.

About Sequana Medical

Sequana Medical is a commercial-stage medical device company using its alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments against fluid overload in liver diseases, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a common complication of many major diseases, including advanced liver disease caused by NASH-related cirrhosis and heart failure (non-alcoholic steatohepatitis), with resistance to diuretics being widespread. The American market for alfaThe pump resulting from NASH-related cirrhosis is expected to exceed € 3 billion per year over the next 10 to 20 years. The heart failure market for RSD and alfaThe DSR® pump is estimated at more than 5 billion euros per year in the United States and the EU5 by 2026.

The alfaPump is a unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally removed through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and water overload through the use of a sodium-free infusion administered into the abdominal cavity.

In the United States, the Company’s main growth market, alfaThe pump has received revolutionary device designation from the FDA for recurrent or refractory ascites due to cirrhosis of the liver. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive results for all primary endpoints of the study and clinically important rapid and persistent improvement in quality of life. This study is intended to support a future commercialization application of alfapump in the United States and Canada. In Europe, the alfaThe pump is CE marked for the management of refractory ascites due to cirrhosis of the liver and malignant ascites and is included in major clinical practice guidelines. Over 850 alfapumping systems have been installed to date.

Sequana Medical has combined its alfapump and proprietary DSR therapy, and develops the alfaDSR pump, a revolutionary approach to fluid overload due to heart failure. RED DESERT, repeated dose alfaThe Pump DSR study in patients with diuretic resistant heart failure demonstrated that repeated DSR therapy is able to both manage the water and sodium balance of these patients as well as restore their diuretic response and improve their cardio-renal condition. The study of the SAHARA DESERT alfaPump RSD in decompensated heart failure patients is ongoing.

Sequana Medical is headquartered in Ghent, Belgium. For more information, please visit www.sequanamedical.com.

Important Regulatory Disclaimers

The alfapump® is currently not approved in the United States or Canada. In the United States and Canada, the alfapump® is currently under clinical investigation (POSEIDON study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information on the POSEIDON clinical study, see www.poseidonstudy.com. DSR® therapy is still under development and it should be noted that any statements regarding safety and efficacy arise from ongoing preclinical and clinical studies that have not yet been completed. DSR® therapy is not currently approved for clinical research in the United States or Canada. There is no link between DSR® therapy and ongoing investigations with the alfapump® in Europe, the United States or Canada.

To note: alfapump® is a registered trademark. DSR® and alfapump DSR® are trademarks registered in Benelux, China, EU, UK and Hong Kong.

Forward-looking statements

This press release may contain predictions, estimates or other information that may be considered as forward-looking statements. These forward-looking statements are not guarantees of future performance. These forward-looking statements represent Sequana Medical’s current judgment on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or commitment to publish any updates or revisions to any forward-looking statements contained in this press release, except as expressly required by law or regulation. You should not place undue reliance on forward-looking statements, which only reflect the views of Sequana Medical as of the date of this press release..

1 The pre- and post-implant periods for this Roll-In cohort analysis differ from those that will be used for the pivot cohort analysis.

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