Specialty pharmaceutical company Talphera Inc (Nasdaq: TLPH) on Monday announced the enrollment of 17 patients in its 70-patient NEPHRO CRRT pivotal trial, marking a key milestone required to trigger the second tranche of its three-part financing secured in March 2025. The study has now reached around 25% enrollment, with recruitment accelerating through newly activated clinical sites.

The NEPHRO CRRT trial is a prospective, double-blinded study being conducted across up to 14 U.S. hospital intensive care units. It will evaluate Niyad, Talphera's lyophilized nafamostat formulation, in 70 adult patients undergoing renal replacement therapy who cannot tolerate heparin or are at risk of bleeding. The primary endpoint is mean post-filter activated clotting time versus placebo over 24 hours, with additional endpoints including filter lifespan, transfusion requirements and dialysis efficacy.

Niyad, which has received Breakthrough Device Designation from the U.S. Food and Drug Administration, is being developed as an anticoagulant for the extracorporeal circuit.

Talphera remains on track to complete the study by the end of 2025.