CORMEDIX ANNOUNCES PRESENTATION OF LOCK-IT-100 STUDY RESULTS AT NATIONAL KIDNEY FOUNDATION SPRING 2019 MEETING
May 10, 2019
Berkeley Heights, NJ – May 10, 2019 – 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, is pleased to announce that the results of the LOCK-IT-100 study will be presented at the National Kidney Foundation 2019 Spring Clinical Meetings in Boston, MA.
The presentation entitled “A Phase III, Prospective, Multicenter, Double-Blind, Active Control Study to Demonstrate the Safety and Effectiveness of Neutrolin® in Preventing Catheter-Related Bloodstream Infections in Subjects Receiving Hemodialysis Therapy as Treatment for End Stage Renal Disease,” is being delivered by Anil Agarwal, M.D. at 10:15 am during the Late-Breaking Presentations. Dr. Agarwal, who was an investigator in the study, is a Professor of Medicine at The Ohio State University and a consultant to the Company.
Dr. Agarwal commented, “I am very pleased to present the results of the landmark study and I thank the patients and investigators for their significant contributions to its success.” The data presented for the interim analysis showed that the investigational new drug Neutrolin had a 72% reduction in catheter-related bloodstream infections (CRBSIs) relative to the heparin control arm (p=0.0034) and had a good safety profile. The study was terminated early based on the recommendation of the independent Data Safety Monitoring Board, because efficacy had been demonstrated and the pre-specified level of statistical significance had been achieved with no safety concerns, based on the interim analysis. The full data set with 795 subjects for the completed study showed a 71% reduction in CRBSIs (p=0.0006).
Khoso Baluch, CorMedix CEO commented, “We are proud to have completed the LOCK-IT-100 study. We plan to use this robust evidence of safety and effectiveness of Neutrolin to support marketing authorization in the U.S for preventing CRBSI in hemodialysis patients. This was a very large study with 806 subjects randomized, utilizing an active control across 70 investigational sites in the U.S. The double-blind study provided data on more than 136,000 catheter-days and demonstrates the potential for Neutrolin to address an unmet medical need.”
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 Phase 3 development for 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 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 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 continued development of Neutrolin; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; the costs and time needed to submit a new drug application to the FDA; risks related to obtaining FDA approval of the new drug application for Neutrolin; relying on preclinical results that may not be indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; the risks and uncertainties associated with research for additional uses for taurolidine; risks relating to the effect of the recently-effected reverse stock split on the Company’s stock price and its overall market capitalization; 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.