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Talphera Announces First Patient Enrolled in the Registrational Trial Evaluating Nafamostat for Anticoagulation of the Extracorporeal Circuit
The safety and effectiveness of nafamostat is being assessed in the NEPHRO CRRT registrational trial in 166 patients at up to 14 clinical sites Primary
About this update from Talphera, Inc.
[{"type":"text","content":"The safety and effectiveness of nafamostat is being assessed in the NEPHRO CRRT registrational trial in 166 patients at up to 14 clinical sites \nPrimary endpoint in the NEPHRO CRRT study is measured over the first 24 hours, with patients completing the study after 72 hours\nDr. Stuart Goldstein, a world-renowned nephrologist, is the first physician to enroll a patient in the NEPHRO CRRT study\nSAN MATEO, Calif., Aug. 19, 2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH), (\"Talphera\"), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the first patient has been enrolled in the NEPHRO CRRT study.\nThe NEPHRO CRRT registrational study will enroll 166 patients undergoing continuous renal replacement therapy (CRRT) at up to 14 clinical sites across the United States. The primary endpoint of the study is the mean post-filter activated clotting time for circuits infused with nafamostat versus placebo over the first 24 hours.\n\"We are excited to be able to offer participation in this nafamostat study to our patients requiring CRRT,\" stated Stuart Goldstein, M.D., Professor of Pediatrics and Director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital Medical Center. \"Nafamostat, if approved following this trial, will be a valuable addition to our anticoagulant options for many patients.\"\n\"We are pleased the first patient was enrolled in the study last week. Nafamostat has the potential to address disadvantages of the currently available U.S. products used for anticoagulation of the extracorporeal circuit. Enrolling the first patient in the NEPHRO study is the first of what we believe will be several important milestones for Talphera,\" stated Dr. Shakil Aslam, Chief Development Officer at Talphera. \"Nafamostat has been used, and is a standard of care, in Japan and South Korea for over 30 years and we're excited about the prospects of making nafamostat available to healthcare providers in the United States, if approved,\" continued Dr. Aslam.\nAbout Niyad and nafamostat \nNafamostat is a broad spectrum, synthetic serine protease inhibitor with anticoagulant, anti-inflammatory and potential anti-viral activities. Niyad™ is a lyophilized formulation of nafamostat and is currently being studied...