#United States #Talphera #Niyad #San Mateo, California #Nafamostat

Talphera Inc. Reaches Key Enrollment Milestone in NEPHRO CRRT Trial

Talphera, Inc., a specialized pharmaceutical entity listed on Nasdaq under the ticker TLPH, has reported significant progress in its clinical trial for the NEPHRO CRRT study. Recently, the company achieved a vital milestone by enrolling 17 patients, which accounts for approximately 25% of the targeted 70 participants. This enrollment acceleration is a reflection of heightened efforts from recently activated clinical sites which have added momentum to the recruitment process.

In a statement, Vince Angotti, the CEO of Talphera, expressed optimism about the trial's future, stating, “Just one week after we proudly announced the enrollment of our 15th patient, we are thrilled to report reaching 17. The improvements in our recruitment rate, combined with the expected addition of six new clinical sites by the third quarter, bolster our confidence in completing the study by the end of 2025.” This renewed focus on enrolling patients through new target clinical sites and experienced principal investigators is showing signs of success, as over 90% of current participants are from these newly engaged locations.

Overview of the NEPHRO CRRT Study

The NEPHRO CRRT trial, which has gained approval from a central Institutional Review Board, aims to examine the efficacy and safety of the drug Niyad in a double-blind study format across 14 intensive care units in the United States. The objective is to enroll and assess 70 adult patients requiring renal replacement therapy who cannot tolerate heparin due to bleeding risks. The primary endpoint focuses on measuring the mean post-filter activated clotting time when using Niyad compared to a placebo over the initial 24 hours.

Secondary endpoints include evaluating the mean post-filter activated clotting time over 72 hours, assessing the filter lifespan, tracking the number of filter changes required, documenting any transfusions within the 72-hour period, and determining dialysis effectiveness based on urea concentration in that same timeframe. These measurements are critical for establishing the clinical utility of Niyad in managing anticoagulation during renal replacement therapy.

Niyad and Nafamostat: Key Components

Nafamostat, which serves as the active ingredient in Niyad, is a synthetic serine protease inhibitor known for its anticoagulant and anti-inflammatory properties and potential effectiveness against viruses. Niyad is a freeze-dried version of nafamostat that is under an investigational device exemption (IDE) for use as an anticoagulant during extracorporeal circulatory procedures. This product has received Breakthrough Device Designation from the FDA, signifying its importance in clinical practice. The study examining Niyad, known as the NEPHRO CRRT study, is a pivotal step toward understanding its role in enhancing the management of patients undergoing renal treatments that necessitate anticoagulation.

Additionally, the company has implemented an ICD-10 procedural code, XY0YX37, which is directly associated with the extracorporeal introduction of nafamostat. This coding is beneficial for healthcare providers, enabling easier documentation and billing for procedures using this innovative treatment.

Talphera’s ongoing research also includes investigating LTX-608, a proprietary formulation of nafamostat designed for direct intravenous infusion. This variant may be explored for uses in treating conditions such as acute respiratory distress syndrome, disseminated intravascular coagulation, and acute pancreatitis, along with potential applications in antiviral therapies.

Looking Ahead

Talphera’s journey toward advancing innovative therapeutics through the NEPHRO CRRT pivotal trial illustrates not only the company’s commitment to developing clinical solutions but also the potential impact of Niyad in improving patient outcomes in renal replacement therapies. With confidence in their planned completion timeline by late 2025, Talphera aims to continue building upon this progress by ensuring robust participation and successful trial results that may pave the way for transformative treatment options in critically ill populations needing renal support.

For more information about Talphera, visit their corporate website at www.talphera.com.