FDA Accepts CorMedix’ Pivotal Phase 3 Study Protocol
CorMedix announced that the U.S. Food and Drug Administration (FDA) has agreed with the design of our pivotal Phase III protocol for Neutrolin in Hemodialysis patients, and the company plans to submit the IND for Neutrolin within the next 30 days. The FDA will then have 30 days to respond to the IND. The pivotal Phase 3 randomized controlled trial ("RCT") for Neutrolin is for use in hemodialysis patients with a central venous catheter. The Phase 3 clinical trial will be a multi-center, randomized, controlled study conducted in the U.S. 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 program.
In addition, CorMedix is pleased to announce strategic business collaboration with Wonik Corporation, a South Korean corporation with a strong medical device franchise within the Korean healthcare market. Wonik has a strong medical franchise and we believe it is well positioned to market, sell and distribute Neutrolin for hemodialysis patients upon receipt of regulatory approval in Korea.
Randy Milby, Chief Executive Officer of CorMedix, stated, "I am very pleased to have signed a definitive agreement with an established commercial partner, Wonik Group in South Korea, a professional and growing healthcare company in one of the key markets in East Asia. It will of course take some time to gain regulatory approval to market the product." "In addition, the acceptance of the Neutrolin pivotal Phase 3 clinical trial protocol is a major milestone which provides us with a clearly defined development and regulatory pathway for Neutrolin in the United States, and we would like to thank the FDA for its continued guidance throughout this process."