Successful Phase III LOCK-IT-100 study of Neutrolin to reduce the risk of occurrence of catheter-related bloodstream infections.- CorMedix Inc.

CorMedix Inc. a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced that the independent Data Safety Monitoring Board (DSMB) has completed its review of the interim analysis of the data from the currently ongoing Phase III LOCK-IT-100 study for Neutrolin (taurolidine 1.35%, citrate 3.5% and heparin). Because the pre-specified level of statistical significance was reached and efficacy had been demonstrated, the DSMB recommended the study be terminated early.

No safety concerns were reported by the DSMB based on the interim analysis. The company will submit the results of the interim analysis to the FDA for its review. The primary endpoint of the Phase III LOCK-IT-100 study is reducing the risk of occurrence of CRBSI (catheter-related bloodstream infections) by Neutrolin relative to the active control of heparin. The secondary endpoints are catheter patency, which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction, and catheter removal for any reason.

Comment: Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP market exclusivity in the event of U.S. approval. Neutrolin is treated as device in the EU and has a CE mark.