Belgian-headquartered Sequana Medical has enrolled the first patient in the North American pivotal study of the alfapump for the treatment of recurrent and refractory ascites due to liver cirrhosis, to support marketing approval and reimbursement of the alfapump in the U.S. and Canada.
The primary effectiveness outcome of the study will include the proportion of patients with a 50% reduction in overall average frequency of paracentesis per month post-implantation versus pre-implantation, Sequana said. This endpoint will be evaluated at nine months after enrolment. Patients will be followed for up to two years after implantation for analysis of secondary outcome measurements.
Top-line results from the study are expected in 2021 and the company expects to launch the alfapump in the U.S. in the first half of 2022.
Professor Florence Wong at the University of Toronto, Hepatologist at Toronto General Hospital, Ontario, Canada and Principal Investigator in the study, said: “The medical community in North America is becoming increasingly aware of other treatment options for patients with cirrhosis complicated by recurrent or refractory ascites, rather than accepting large volume paracentesis as the only treatment option. The alfapump has a proven track record in Europe, where it is already being used commercially, and we believe this technology has the potential to address this difficult-to-treat condition in these patients and significantly improve their quality of life.”
Ian Crosbie, Chief Executive Officer at Sequana Medical, said: “The start of the POSEIDON study is another important milestone for Sequana Medical and the next step in bringing the alfapump as a treatment option to patients in North America. We believe there is significant growth potential in this growing and dynamic market where we anticipate the alfapump will have a stronger competitive position due to the increasing prevalence of NASH-related cirrhosis and the inconveniences posed by the current standard of care. We look forward to reporting further progress of the study and expect patient recruitment to be completed by mid-2020 with top-line results anticipated by mid-2021.”