CorMedix Inc, a pharmaceutical company focused on developing and commercialising therapeutic products for the prevention and treatment of cardiorenal and infectious disease, announced the progress of on-going discussions with the US Food and Drug Administration for a planned pivotal Phase 3 randomised controlled trial (“RCT”) for Neutrolin for use in hemodialysis patients with a central venous catheter. CorMedix worked with the FDA to develop the protocol design for the planned trial for a marketing application. Based on FDA input, the planned Phase 3 clinical trial will be a multi-centre, randomied, controlled study conducted in the US. and Europe. Dr. Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 programme.
In addition, CorMedix has earlier submitted detailed information to TUV-SUD for the purpose of advancing our label expansion in the European Union to include oncology, total parenteral nutrition and intensive care patients.
Randy Milby, Chief Executive Officer of CorMedix, stated, "The planned Neutrolin pivotal Phase 3 clinical trial is a major milestone which provides us with a clearly defined development and regulatory pathway for Neutrolin, and we would like to thank the FDA for its invaluable guidance throughout this process." “We believe that Neutrolin is well positioned to unlock significant shareholder value."
CorMedix Inc. is a commercial-stage pharmaceutical company that seeks to in-license, develop and commercialise therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. CorMedix's first commercial product in Germany is Neutrolin, a catheter lock solution for the prevention of catheter related bloodstream infections and maintenance of catheter patency in tunneled, cuffed, central venous catheters used for vascular access in hemodialysis patients.