CorMedix Inc. announced the topline results of the interim analysis of the Company’s Phase 3 LOCK-IT-100 study for Neutrolin® as a catheter lock solution in hemodialysis patients. As previously announced, the study was terminated at the recommendation of the independent Data Safety Monitoring Board (DSMB) after the interim analysis was completed in July 2018, because efficacy had been demonstrated and the pre-specified level of statistical significance had been achieved. The DSMB reported that there were no safety concerns. In the Neutrolin arm, there was a 72% reduction in the risk of occurrence of catheter-related blood stream infections (CRBSI), which was the primary endpoint of the study, compared with the active control of heparin. The interim analysis was conducted, as pre-specified, when the results of the first 28 cases of CRBSIs were available. The interim analysis of these cases showed that the 72% reduction of CRBSI by Neutrolin was well in excess of the study’s assumed treatment effect size of a 55% reduction. The impressive treatment effect of Neutrolin was highly statistically significant (p=0.0034). The DSMB also reviewed the available safety data and identified no concerns. CorMedix remained blinded to the results of the interim analysis until after the database was recenty locked at study completion.