DefenCath® (taurolidine and heparin) catheter lock solution is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

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CORMEDIX INC. ANNOUNCES ABSTRACT PRESENTATION AT UPCOMING AMERICAN SOCIETY OF NEPHROLOGY CONFERENCE

Berkeley Heights, NJ – October 20, 2022 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that an abstract has been accepted for presentation at the American Society of Nephrology (ASN) annual meeting being held in Orlando, Florida, November 3 – 6.

The abstract being presented highlights a retrospective analysis that was conducted integrating multiple clinical and claims databases that track kidney failure patients. The conclusions from this study further highlight the significant incidence of and morbidity and mortality related to catheter-related bloodstream infections (CRBSIs). These findings are especially important since approximately 80% of patients undergoing hemodialysis start with a central venous catheter (CVC) as their first vascular access. Key findings include:

  • Approximately 33% of the ~51k hemodialysis patients studied had an occurrence of CRBSI post CVC-insertion
  • 47% of CRBSIs occurred within 3 months following CVC insertion, 33% within 1 month
  • CRBSIs led to high rates of stroke, myocardial infarction, peripheral vascular disease and heart failure, and generally longer and more costly hospital admissions, and a more complicated clinical course

Joseph Todisco, Chief Executive Officer of CorMedix commented, “The abstract being presented represents important work by the CorMedix team to highlight the magnitude and severity of CRBSIs as a critical and unmitigated problem in the hemodialysis patient community. CorMedix has demonstrated in a Phase 3 clinical study that DefenCath can reduce the incidence of CRBSIs in CVC patients undergoing hemodialysis by approximately 71%.  As we continue to work toward FDA approval and commercialization of DefenCath, we are motivated by these data findings that reinforce the significant unmet medical need that CRBSI’s pose to the hemodialysis community.”

The abstract is included below and available through the American Society of Nephrology conference website.

ASN Conference Abstract:

Rapid Incidence and Emergence of Catheter-Related Blood Stream Infections (CRBSIs) Among CVC-Dependent HD Patients

Abstract: TH-PO276

Background: Kidney failure patients receiving hemodialysis (HD) via a central venous catheter (CVC) are at high risk of developing catheter-related bloodstream infections (CRBSIs), resulting in increased mortality, hospitalizations, and long-term complications (LTCs). A claims-based algorithm was developed to assess real-world outpatient/inpatient (OP/IP) CRBSIs among CVC-dependent HD (CVC-HD) patients. 

Methods: A retrospective analysis of merged data from United States Renal Data System (USRDS), CROWNWeb (dialysis orgs.), and Medicare claims (2013-2018) was conducted. Among incident CVC-HD (2014-2017) patients with 1 year pre- and ≥ 1-year post-index data (n=51,783), CRBSI incidence was the first date of OP/IP CRBSI occurrence. OP CRBSI was the first oral/intravenous antibiotic prescription within ±1 day of the first OP emergency/urgent care visit post-CVC insertion. IP CRBSI was the first occurrence of either sepsis/bacteremia and ICD-9/10 CMs 999.32, T80211x; 999.31, T80219x, T80218x claims or sepsis/bacteremia diagnosis without occurrence for pneumonia, gangrene, or urinary tract infections. CRBSI incidence proportion and rates, median days to CRBSI, proportion of CRBSIs at days 30 and 90, and 1-year post-CRBSI LTC rates were assessed.

Results: The CVC-HD cohort’s mean age was 63 (SD:15.3); 47% (n=7,822) were female and 29% (n=4,898) were African American. CRBSI incidence proportion and rates were approximately 33% (n=16,813) and 4.5 per 1000-catheter days, respectively. In total 81% (n=13,559) of CRBSIs were diagnosed IP and 19% (n=3,254) were diagnosed in OP settings. Overall, 33% and 47% developed CRBSIs within 30- and 90-days post-CVC insertion, respectively. Median days to CRBSI were 107 days (interquartile range: 294 days). Frequently reported LTCs were HF (58%), dysrhythmia (54%), PVD (41%), stroke (17%), and MI (13%). 

Conclusion: Of the 1/3rd of CVC-HD patients with CRBSIs, 33% and 47% developed CRBSI within 30- and 90-days post-CVC insertion, respectively. High rates of HF, PVD, stroke, and MI were reported 1-year post-CRBSI. Assessment of the incremental burden of clinical complications and costs associated with CRBSIs is warranted and underway. Early and high incident CRBSI rates underscore the importance of interventions that can prevent CRBSIs among CVC-HD patients.

About CorMedix

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. The Company received a Complete Response Letter (CRL) from FDA stating that the original NDA could not be approved until deficiencies at the contract manufacturing organization (CMO) were satisfactorily resolved.  FDA notified the Company in a second CRL that the refiled NDA could not be approved until satisfactory resolution of deficiencies identified during a pre-approval inspection at the CMO and during an inspection for an unrelated active pharmaceutical ingredient at the manufacturing facility for the heparin supplier for DefenCath.  CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations.  The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.  Neutrolin® is CE Marked and has been marketed in Europe and other territories as a medical device. For more information, visit: www.cormedix.com.

Forward-Looking Statements

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, CorMedix’s plans to submit a resubmission of its NDA application for DefenCath and the timing of such submission; CorMedix’s plans regarding the submission of a duplicate NTAP and the timing of such submission, 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 ability of the CMO to address the deficiencies identified by the FDA; the ability of the Company’s heparin supplier to address the manufacturing deficiencies identified in the warning letter for non-heparin API;  the resources needed to secure approval of the NDA for DefenCath from the FDA;  the risks and uncertainties of the relationships with the additional CMO and supplier of heparin; the ability to submit a supplement to CorMedix’s NDA by the end of the first quarter of 2023; the ability to secure final FDA approval prior to July 1, 2023 or obtain CMS approval of a resubmitted NTAP application;  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 DefenCath/Neutrolin 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. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. 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.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
(617) 430-7576