The US Food and Drug Administration (FDA) has agreed on the design of US-based pharmaceutical firm CorMedix’s pivotal Phase III protocol for Neutrolin to treat Hemodialysis patients.
The company also intends to submit the investigational new drug (IND) application for Neutrolin within the next 30 days and the FDA will then have 30 days to respond to the IND.
The Phase III randomised controlled trial (RCT) for Neutrolin is for the treatment of hemodialysis patients with a central venous catheter.
University of Alabama professor of Department of Medicine, Division of Nephrology Dr Michael Allon will be the study chair of the multi-centre, randomised, controlled Phase III Neutrolin trial, which will be conducted in the US and Europe.
Additionally, the company has entered into a strategic business collaboration with Wonik, a South Korean corporation with a strong medical device franchise within the Korean healthcare market.
The company said that Wonik is well positioned to market, sell and distribute Neutrolin for hemodialysis patients upon receipt of regulatory approval in Korea.
CorMedix chief executive officer Randy Milby said: "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."
The company seeks to in-license, develop and commercialise therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases.
Neutrolin, a catheter lock solution, is the company’s first commercial product in Germany, 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.