Talphera Hits 50% Enrollment in NEPHRO-CRRT Trial After 60% Patient Cut
Talphera has enrolled 35 of 70 patients (50%) in its NEPHRO-CRRT registrational study after FDA-agreed protocol changes, including a 60% reduction in target enrollment and a shift to medical ICUs with nephrologist principal investigators. The company plans to file a PMA this year for Niyad™, potentially the only FDA-approved regional anticoagulant for CRRT.
1. Enrollment Milestone Achieved
Talphera enrolled 35 out of 70 patients in its NEPHRO-CRRT registrational trial, reaching a 50% enrollment milestone. This achievement follows streamlined screening processes and targeted site selection to accelerate patient recruitment.
2. Protocol Modifications and Site Focus
With FDA agreement, Talphera reduced total enrollment by nearly 60% and updated site criteria to concentrate on medical intensive care units led by nephrologists, resulting in over 90% of patients originating from these new locations.
3. PMA Filing and Investor Event
The company anticipates filing a premarket approval application for Niyad™ this year, aiming to secure the first FDA-approved regional anticoagulant for CRRT. A virtual investor and analyst event is scheduled for March 23 at 11:00 am ET featuring nephrologists Dr. Blaithin McMahon and Dr. Joao Teixeira.