CorMedix Inc. Demonstrates Sensitivity of Emerging Global Health Threat Candida auris to Taurolidine
Bedminster, NJ – May 9, 2017 – CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced the results of a special culture sensitivity test of taurolidine, the anti-infective component of Neutrolin®, the Company’s catheter lock solution currently marketed in the EU and in Phase 3 trials in the U.S., against Candida auris. The sensitivity testing, performed by premier microbiology and antimicrobial surveillance laboratory JMI Laboratories, demonstrated that C. auris isolates were inhibited 100% at the concentration of taurolidine currently contained in Neutrolin.
Multidrug-resistant C. auris is an emerging fungus causing serious illness in humans that the CDC has cited as an “serious global health threat.” C. auris is associated with life-threatening bloodstream and wound infections, causing recent hospital outbreaks globally with high mortality. It is also able to form biofilms that enhance its pathogenicity and persistence in the hospital setting1.
Antony E. Pfaffle, M.D. Chief Scientific Officer and Co-Founder of CorMedix stated, “Patients at the highest risk of C. auris infection include those with central venous catheters, have undergone recent surgery, have diabetes, and have used broad-spectrum antibiotics and antifungals2. C. auris often does not respond to commonly used antifungal drugs, making infections difficult to treat. For this reason, we are pleased to see that taurolidine appears to completely inhibit this deadly pathogen in laboratory studies. The broad spectrum activity underscores the potential utility of taurolidine for development not only as the active ingredient in Neutrolin but also were it to be incorporated into sutures, hydrogels and surgical meshes in indications such as wound closure, burns, and diabetic foot ulcer. We look forward to determining a plan to work with global regulatory agencies to leverage the benefits of taurolidine to help prevent resistant microbial infections.”
Doug Webb, Ph.D., a member of the Faculty of Medicine at Mercer Medical College and former Director of Anti-Infectives at Pfizer, stated, “The in vitro sensitivity testing of taurolidine vs. C. auris looks very encouraging as it shows significant inhibition of this fungus, which is becoming more and more prevalent in the acute care hospital setting.”
Bruce Polsky, M.D., Chairman of the Department of Medicine at NYU Winthrop Hospital, said, “In conducting these tests, CorMedix has demonstrated a commitment to developing both preventative and therapeutic agents like its taurolidine-based solution, which may be effective against troublesome pathogens like C. auris that can cause catheter-related bloodstream infections.”
About CorMedix Inc.
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease. 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. Such infections cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin is currently in a Phase 3 clinical trial in patients undergoing chronic hemodialysis via a central venous catheter. The Company is planning to conduct its second Phase 3 clinical trial in patients with cancer receiving IV parenteral nutrition, chemotherapy and hydration via a chronic central venous catheter, subject to sufficient resources. If successful, the two pivotal studies may be submitted to the FDA for potential approval for both patient populations. 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 upon U.S. approval. It is already a CE Marked product in Europe and other territories. For more information, visit: www.cormedix.com.
1Sherry, L., Ramage, G., Kean, R., Borman, A., Johnson, E. M., Richardson, M. D., Rautemaa-Richardson, R. (2017). Biofilm-Forming Capability of Highly Virulent, Multidrug-Resistant Candida auris. Emerging Infectious Diseases, 23(2), 328-331. https://dx.doi.org/10.3201/eid2302.161320.
2Centers for Disease Control and Prevention (2017). Candida auris Questions and Answers https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris-qanda.html
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: preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on planned or future research, including for additional uses for taurolidine; 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; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; 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.
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