Sequana Medical completes enrollment in Phase 2a SAHARA I DSR study, reports disease-modifying profile for Short Term DSR and provides business update
DSR (Direct Sodium Removal) heart failure drug development:
- Completed enrollment in SAHARA I[i] with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US IND[ii] filing by year end
- Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable improvements in validated clinical measures
- Heart failure disease-modifying profile – safe, rapid and effective decongestion with no congestion-related heart failure re-hospitalizations observed
- Clinical outcomes from RED DESERT and SAHARA result in a 75% reduction in predicted one-year mortality based on Seattle Heart Failure model[iii]
- Heart failure development program to focus on Short Term DSR with DSR 2.0 alfapump® in North America:
- Submission of Premarket Approval (PMA) to the US FDA expected in H2 2023
Webcast and conference call for investors/analysts today at 3:00 pm CEST / 9:00 am ET
Ghent, Belgium – 19 July 2022 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease and heart failure, today announces the completion of enrollment in its Phase 2a SAHARA proof-of-concept study using its first-generation DSR product (“DSR 1.0”) as treatment for congestive heart failure. Sequana Medical intends to extend SAHARA to treat a small number of patients with its proprietary second-generation DSR product (“DSR 2.0”) to support the US IND filing, expected by year end.
