CorMedix, Inc. Awarded NIH Grant to Develop Advanced Antimicrobial Hydrogels for the Treatment and Prevention of Potentially Life-Threatening Infections in Severe Burns
Bedminster, NJ – August 17, 2017 – 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 it has secured a research grant from the National Institutes of Health (NIH) to expand the Company’s antimicrobial hydrogel medical device program. In addition to CorMedix’s ongoing development of taurolidine-incorporated hydrogels to reduce infections in common burns, this funding will finance the development of an advanced hydrogel formulation that is designed to reduce the risk of potentially life-threatening infection and promote healing of more severe burn injuries, for which there is significant need.
Khoso Baluch, CorMedix Chief Executive Officer stated, “This grant funding enables CorMedix to broaden our anti-infective hydrogel development program and validates our scientific approach to the use of taurolidine in a variety of certain medical device applications. We are pleased to be awarded this grant, which was based on a Request for Proposal from the NIH to address the need for antiseptic products that can penetrate to the site of infection in deeper, more severe burns. With access to this capital, we can pursue development of this advanced hydrogel formulation in parallel with our first-generation taurolidine-based hydrogels intended to treat common topical burns, rather than in sequence. It may also provide a second near-term hydrogel product opportunity for CorMedix without drawing from our current cash.”
CorMedix’s Director of R&D Robert DiLuccio, Ph.D., and Scientific Advisory Board member Bruce Reidenberg, M.D., will serve as Co-Principle Investigators, working with esteemed development partners at The University of Florida, University of Miami, and the New Jersey Center for Biomaterials (NJCBM) at Rutgers University to develop a topical hydrogel that delivers taurolidine encased in a nanoparticle. This approach is designed to enable nanoparticles loaded with taurolidine to effectively penetrate through damaged epidermal skin layers and release antimicrobial taurolidine at the site of infection, allowing prevention and treatment of potentially life-threatening burn-related infections, including those caused by pathogens that have already been found to be resistant to currently used antiseptics.
Dr. DiLuccio commented, “Burn injury care has improved in the past decades, but more severe burns carry additional complications including bacterial infections that often lead to longer hospital stays and increased risk of death. In vitro studies of our first-generation hydrogels demonstrated strong proof-of-concept by effectively killing bacteria suspended in cultures as well as in mature biofilms, which are more resistant to current antibiotics. We look forward to developing this advanced, nanoparticle-delivered taurolidine hydrogel to reach deeper layers of the skin, which may enhance the antimicrobial efficacy and better promote healing of severe burns. As we highlighted at our recent R&D Day, all of our active medical device development programs, which include antimicrobial sutures and surgical meshes, are expected to follow an accelerated and cost-effective FDA regulatory pathway.”
This program is supported by the National Institute of General Medical Sciences of the National Institutes of Health under Award Number R43GM122156. The content of this press release is solely the responsibility of CorMedix and does not necessarily represent the official views of the National Institutes of Health.
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 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. 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 working on the design of a planned second Phase 3 clinical trial, which, if approved, would be subject to sufficient resources. 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.
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 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; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; 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; 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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