Talphera Reaches 50% Enrollment in Nafamostat CRRT Trial, Targets 2026 FDA Filing
核心洞察
Talphera has enrolled 35 of 70 patients (50% enrollment) in its NEPHRO-CRRT registrational trial testing nafamostat as an anticoagulant for continuous renal replacement therapy.
The company implemented FDA-approved protocol changes including a 60% reduction in patient enrollment requirements and focused on medical ICUs with nephrologists as principal investigators.
Talphera plans to complete the study and file a Premarket Approval (PMA) application in 2026, potentially making nafamostat the only FDA-approved regional anticoagulant for CRRT.
Talphera has achieved a significant milestone in its pivotal clinical trial for nafamostat, reaching 50% patient enrollment in the NEPHRO-CRRT registrational study. The specialty pharmaceutical company enrolled 35 of the planned 70 patients, with over 90% of participants recruited from newly targeted clinical sites focused on medical intensive care units with nephrologists as principal investigators.
Strategic Protocol Modifications Drive Enrollment Success
The company implemented substantial changes to the NEPHRO-CRRT clinical trial throughout 2025 with FDA agreement, including a nearly 60% reduction in the total number of patients required for enrollment. These modifications, combined with revised enrollment criteria and an updated target profile for clinical sites, have yielded positive results in enrollment rates.
"Over the course of 2025, with agreement from the FDA, we implemented significant changes to the NEPHRO CRRT clinical trial, including a nearly 60% reduction in the total number of patients to be enrolled and revising other enrollment criteria," said Vince Angotti, CEO of Talphera. "These changes have yielded positive results in enrollment rates, allowing us to achieve our 50% enrollment milestone with more than 90% of the patients from our new sites."
All 12 clinical study sites are now able to enroll patients and are expected to support increased enrollment rates for the remainder of the study. The company anticipates completing the trial later in 2026.
Addressing Critical Unmet Medical Need
The NEPHRO-CRRT study is designed as a prospective, double-blinded trial conducted at up to 14 U.S. hospital intensive care units. The study evaluates 70 adult patients undergoing renal replacement therapy who cannot tolerate heparin or are at risk for bleeding. The primary endpoint measures mean post-filter activated clotting time using nafamostat versus placebo over the first 24 hours.
Key secondary endpoints include mean post-filter activated clotting time over 72 hours, 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.
Principal investigators remain highly motivated by the prospect of having nafamostat potentially approved for use during CRRT, given their dissatisfaction with current anticoagulants. "We continue to receive feedback from physicians—that they desperately need a better CRRT anticoagulant," Angotti noted.
Regulatory Pathway and Commercial Potential
Nafamostat is a broad spectrum, synthetic serine protease (搜索) inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad (搜索), Talphera's lyophilized formulation of nafamostat, is currently being studied under an investigational device exemption (IDE) as an anticoagulant for the extracorporeal circuit and has received Breakthrough Device Designation status from the FDA.
The company plans to file a Premarket Approval (PMA) application in 2026, potentially positioning nafamostat as the only FDA-approved regional anticoagulant for CRRT. An ICD-10 procedural code, XY0YX37, has already been issued for the extracorporeal introduction of nafamostat.
Financial Position and 2026 Outlook
Talphera reported cash and investments of $20.4 million as of December 31, 2025, compared to $8.9 million at the end of 2024. The company closed a $4.1 million third tranche of its March 2025 private placement financing upon achieving the 35-patient enrollment milestone.
For 2026, cash operating expenses are expected to range from $17 million to $18 million, representing an increase from approximately $13 million in 2025. This increase is driven by NEPHRO-CRRT study expenses and related chemistry, manufacturing, and controls (CMC) expenses and validation batches expected prior to PMA filing.
Combined research and development and selling, general and administrative expenses for the fourth quarter of 2025 totaled $3.5 million compared to $3.0 million for the fourth quarter of 2024. Net loss attributable to common shareholders for the fourth quarter was $3.8 million, or $0.06 per basic and diluted share.