Talphera Makes Progress in Niyad™ Clinical Trial with Increased Patient Enrollment

Talphera Advances Clinical Trial for Niyad™ Amid Growing Enrollment

Talphera, Inc., a specialty pharmaceutical company, announces significant progress in its pivotal NEPHRO CRRT clinical trial, having enrolled approximately 25% of the target patient population. With 17 patients now participating out of a planned 70, the trial assesses the safety and efficacy of Niyad™, a nafamostat formulation intended as an anticoagulant for adult patients undergoing renal replacement therapy who are at increased risk of bleeding. This achievement is particularly crucial as it meets a condition necessary for closing the second tranche of a financing initiative first disclosed in March 2025, thereby reinforcing Talphera’s financial health as it navigates the complexities of drug development.

The acceleration in patient enrollment is attributed to the strategic addition of six new clinical sites, with these locations expected to begin patient recruitment in the third quarter. CEO Vince Angotti emphasizes that over 90% of the currently enrolled patients come from these newly added sites, bolstering the company's confidence in completing the study by the end of 2025. The NEPHRO CRRT trial, a prospective, double-blinded study, spans up to 14 intensive care units across the U.S., reflecting Talphera’s commitment to rigorous clinical standards. With a primary endpoint focusing on the mean post-filter activated clotting time over the initial 24 hours, the trial also evaluates secondary endpoints related to filter lifespan and dialysis efficacy over a 72-hour period.

Niyad™ has garnered Breakthrough Device Designation Status from the FDA, underscoring its potential to significantly impact patient care in critical settings. This designation not only highlights the innovative nature of Talphera’s development but also paves the way for expedited review processes, crucial for bringing this promising therapy to market. As the company continues its focus on advancing novel therapies in medically supervised environments, the successful execution of the NEPHRO CRRT study stands as a pivotal step in enhancing treatment options for patients in need.

In addition to the trial's progress, Talphera remains committed to fostering partnerships within the healthcare community to support the broader adoption of advanced therapies. The ongoing collaboration with clinical sites reflects a growing recognition of the importance of innovative anticoagulant solutions in managing the complex needs of patients receiving renal replacement therapy. This initiative not only positions Talphera as a leader in specialty pharmaceuticals but also underscores its dedication to improving patient outcomes through targeted and effective interventions.