Talphera Begins Nafamostat Anticoagulation Trial with First Patient Enrolled

Talphera, Inc. (Nasdaq: TLPH), a specialty pharmaceutical company dedicated to developing and commercializing innovative therapies for medically supervised environments, has commenced patient enrollment in the NEPHRO CRRT study. This trial is designed to evaluate the safety and effectiveness of nafamostat in patients undergoing continuous renal replacement therapy (CRRT). The study will involve 166 patients across up to 14 clinical sites in the United States.

The NEPHRO CRRT study primarily aims to measure the mean post-filter activated clotting time in circuits infused with nafamostat compared to those with a placebo over the initial 24 hours. Patients will complete the study after 72 hours. The first patient was enrolled by Dr. Stuart Goldstein, a renowned nephrologist and Director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital Medical Center. Dr. Goldstein stated, “We are excited to offer participation in this nafamostat study to our patients requiring CRRT. If approved, nafamostat will be a valuable addition to our anticoagulant options.”

Dr. Shakil Aslam, Chief Development Officer at Talphera, expressed satisfaction with the study's progress, stating, “Enrolling the first patient in the NEPHRO study marks the first of several important milestones for Talphera. Nafamostat has been a standard of care in Japan and South Korea for over 30 years, and we are eager to bring its benefits to the U.S. healthcare system.”

Nafamostat is a synthetic serine protease inhibitor with anticoagulant, anti-inflammatory, and potential antiviral properties. Talphera's lead product, Niyad™, a lyophilized formulation of nafamostat, is currently being studied under an investigational device exemption (IDE). Niyad™ has received Breakthrough Device Designation status from the FDA, indicating its potential to offer significant advantages over existing treatments.

The NEPHRO CRRT study, standing for Nafamostat Efficacy in Phase 3 Registrational Continuous Renal Replacement Therapy, is a prospective, double-blinded trial. It has received central IRB approval and will be conducted in hospital intensive care units across the U.S. The study will include patients who cannot tolerate heparin or are at risk of bleeding. The primary endpoint is the mean post-filter activated clotting time over the first 24 hours, while secondary endpoints include filter lifespan, number of filter changes over 72 hours, number of transfusions over 72 hours, and dialysis efficacy based on urea concentration over the first 24 hours.

In addition to Niyad™, Talphera is investigating LTX-608, a proprietary nafamostat formulation for direct IV infusion. LTX-608 may be developed for the treatment of acute respiratory distress syndrome (ARDS), disseminated intravascular coagulation (DIC), acute pancreatitis, or as an antiviral treatment.

Talphera, Inc. is focused on developing and commercializing innovative therapies for use in medically supervised settings. The company's primary product candidate, Niyad™, is under investigation as an anticoagulant for the extracorporeal circuit and has received Breakthrough Device Designation from the FDA.

The ongoing NEPHRO CRRT study represents a significant step forward in evaluating nafamostat's potential benefits. By successfully enrolling patients and conducting this rigorous trial, Talphera aims to provide an important new treatment option for patients undergoing CRRT. If successful, nafamostat could address some of the limitations of current U.S. anticoagulant products and improve patient outcomes in critical care settings.