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Talphera Reaches Halfway Point in NEPHRO-CRRT Trial

Talphera, Inc., a pharmaceutical company focused on innovative medical therapies, recently announced a significant milestone in its ongoing NEPHRO-CRRT clinical trial. The company has successfully enrolled 35 out of the planned 70 patients, marking 50% completion of patient enrollment in this critical study.

Background of NEPHRO-CRRT Trial

The NEPHRO-CRRT trial aims to evaluate the efficacy and safety of Niyad™, a formulation of nafamostat, as an anticoagulant suitable for patients undergoing continuous renal replacement therapy (CRRT). These patients are typically unable to tolerate heparin due to bleeding risks—a common concern in critical care settings. This study is being conducted across multiple medical intensive care units (ICUs) in the United States.

In 2025, Talphera made significant modifications to the trial, which included reducing the total enrollment number by nearly 60% and updating criteria to improve participant selection. According to CEO Vince Angotti, these adjustments have indeed had a positive impact, with over 90% of current enrollees coming from newly targeted clinical sites that feature nephrologist principal investigators.

Vince Angotti expressed optimism about completing the study, highlighting the pressing need among healthcare providers for a more effective anticoagulant in CRRT. As Talphera prepares to potentially file a Premarket Approval (PMA) with the FDA later this year, the company is aiming to become the first to obtain regional approval for nafamostat as a CRRT anticoagulant.

Upcoming Virtual Investor Event

On March 23, 2026, Talphera will host a virtual event aimed at investors and analysts. This session will feature two key nephrology experts, Dr. Blaithin McMahon and Dr. Joao Teixeira, who will share insights from their experiences with CRRT. They will discuss the current anticoagulants in use and how nafamostat could fill existing gaps in treatment protocols.

For those interested, the event will be accessible through Talphera's website and will include a slide presentation. A replay will be made available for a duration of 90 days post-event.

Profiles of Key Speakers

Dr. Blaithin McMahon

Dr. McMahon serves as an Associate Professor of Medicine at the Medical University of South Carolina (MUSC) and is recognized for her contributions to the field of Acute Kidney Injury (AKI). With over 50 publications in top nephrology journals, she is heavily involved in clinical trials and directs nephrology studies at MUSC.

Dr. Joao Teixeira

With credentials as an Associate Professor at the University of New Mexico, Dr. Teixeira has made significant strides in critical care nephrology. His expertise encompasses acute kidney injury, septic shock management, and CRRT protocols. His research contributions are extensive, with over 100 peer-reviewed publications and numerous presentations at leading medical conferences.

Conclusion

As Talphera approaches its target of completing the NEPHRO-CRRT study, the implications of this research could be transformative for patients at risk of bleeding during CRRT procedures. With key healthcare experts involved and a focused approach to clinical trials, Talphera is positioned at the forefront of advancing therapeutic solutions in critical care.

For more updates and information on Talphera's endeavors, visit Talphera's official website.