CorMedix Inc. Achieves Target Number of Events in Its LOCK-IT-100 Study of Neutrolin® for Interim Efficacy Analysis
Berkeley Heights, NJ – February 20, 2018 – CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that the Clinical Adjudication Committee (CAC), established to critically and independently assess catheter-related bloodstream infections (CRBSIs), has reviewed potential cases of CRBSI in the Company’s LOCK-IT-100 study of hemodialysis patients with central venous catheters that occurred through early December 2017, and identified 28 such cases. As previously agreed with FDA, an interim analysis will be performed when the first 28 CRBSIs case have been identified. The primary endpoint for the study is the reduction of CRBSI by Neutrolin in comparison to a heparin catheter lock solution.
The Company is currently directing standard procedures to ensure the accuracy and completeness of the data required for conducting the interim analysis. This review includes data for all subjects in the study needed to assess the two secondary endpoints related to a reduction in catheter removal and catheter blockage, as well as the primary endpoint and safety information. Before the full dataset can be locked and the interim analysis can proceed, a number of weeks will be required to complete the quality assurance procedures appropriate for the amount of data generated in the trial. The interim analysis will be provided to the Data Safety Monitoring Board for its review and recommendation upon completion. The Company anticipates that DSMB review will occur in the second quarter of 2018.
Khoso Baluch, Chief Executive Officer of CorMedix stated, “We are excited about the progress we are making and look forward to providing further updates as we achieve the milestones discussed above.”
The Catheter Lock Solution Investigational Trial, or LOCK-IT-100 Trial is a multi-center Phase 3 clinical trial in hemodialysis patients with central venous catheters in the U.S. It is a prospective, randomized, double-blind, active control trial designed to demonstrate the efficacy and safety of Neutrolin in preventing catheter-related bloodstream infections (CRBSI) in subjects receiving hemodialysis therapy as treatment for end stage renal disease. The trial will evaluate whether Neutrolin is superior to the active control heparin by documenting the incidence of CRBSI and the time until the occurrence of CRBSI as the primary endpoint. Key secondary endpoints are catheter patency, which is defined as required use of tissue plasminogen activator (tPA) or removal of catheter due to dysfunction and catheter removal for any reason. LOCK-IT-100 is an event-driven study and study completion is dependent upon capturing 56 total CRBSI events.
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, currently in a Phase 3 clinical trial enrolling patients undergoing chronic hemodialysis. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. 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 already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels. The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information, visit: www.cormedix.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to possible uses of taurolidine, that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the possible inability to capture sufficient CRBSI events in the ongoing Phase 3 clinical trial for Neutrolin®; the cost, timing and results of the ongoing and planned Phase 3 trials for Neutrolin® in the U.S. and the resources needed to commence and complete those trials; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the ongoing LOCK-IT 100 trial and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.