CorMedix Inc. Announces Abstracts at Upcoming Conferences Showing Patient Outcomes and Economic Burden of CRBSI

BERKELEY HEIGHTS, N.J., Oct. 20, 2021 (GLOBE NEWSWIRE) — CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced the acceptance for presentation of three abstracts at industry conferences. These include one abstract presented today at the Association of Managed Care Pharmacy (AMCP) Nexus conference in Denver, Colorado, and two abstracts being presented at the American Society of Nephrology (ASN) conference being held virtually November 4 – 8.

The abstracts being presented highlight retrospective analyses that were conducted integrating multiple clinical and claims databases that track end-stage renal disease (ESRD) patients. The conclusions from these retrospective studies underscore the significant incidence of and mortality related to catheter-related bloodstream infections (CRBSIs) and economic costs related to these infections. 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 29% of the ~56k hemodialysis patients studied had an occurrence of CRBSI post CVC-insertion
• Over 54% of first CRBSIs occurred within 3 months following CVC insertion
• CRBSIs lead to more hospital admissions, longer stays, and a more complicated clinical course
• Hemodialysis related CRBSIs are associated with significant mortality
• Analysis estimates $2.3 billion in direct costs from CVC-CRBSIs annually

Dr. Matt David, interim Chief Executive Officer of CorMedix commented, “The abstracts being presented represent important work by the CorMedix team to expand our understanding of the magnitude of CRBSIs as a problem in the hemodialysis patient community. We have demonstrated in clinical study that DefenCath can reduce CRBSIs in CVC patients undergoing hemodialysis by approximately 71%. As we continue to work to secure marketing authorization for DefenCath, we are motivated by these data that reinforce the unmet medical need that we plan to address by reducing life-threatening CRBSIs.”

The abstracts accepted for presentation are listed below. The AMCP Nexus abstract is published in the JMCP Meeting Abstracts supplement while the ASN abstracts are posted on the conference website.

AMCP Nexus Conference

Title: Incremental Cost of CRBSIs among Central Venous Catheter Dependent Hemodialysis Patients: A Claims-Based Assessment of USRDS linked Medicare Data

Abstract ID: 1066951

Background: For patients undergoing hemodialysis (HD), central venous catheters (CVCs) act as essential vascular access devices. However, CVCs have increased risk of catheter hub contamination that may lead to catheter-related bloodstream infections (CRBSIs) resulting in greater number of hospitalizations, long-term complications (e.g., stroke, heart failure, etc.), and overall costs. To date, the overall cost burden associated with CRBSI is not fully known. Thus, estimating the incremental healthcare resource use and cost burden of CRBSIs is vital.

Objective: To evaluate incremental cost of CRBSIs in HD patients with CVCs.

Methods: A 1:1 propensity score matched case-control analysis was conducted using merged data from United States Renal Data System (USRDS), CROWNWeb (dialysis organizations), and Medicare claims database (2013-2017). All CVC-dependent HD patients from 2014-2016 with a 1-year pre- and ≥ 1-year post-index period were included. CRBSI case group index date was the first date of occurrence of either of the following post CVC insertion: ICD-9/10-CMs 999.32, T80211x; 999.31, T80219x, T80218x and sepsis/bacteremia diagnosis within ±3 days of hospitalization; sepsis/bacteremia diagnosis without occurrence for pneumonia, gangrene, or urinary tract infections within ±3 days of hospitalization. Non-CRBSI control group was identified using an assigned-index date (i.e., CVC insertion date + median days to CRBSI reported in CRBSI-case group). Cohort differences were assessed using frequency, mean, median, chi-square and t-tests. Adjusted generalized linear models (GLM) examined differences in all-cause inpatient hospitalization and total costs between CRBSI and non-CRBSI patients.

Results: Approximately 29% (n=15,863) of the 55,727 HD patients (mean age 67.81 years, 44.6% female) had an occurrence of CRBSI post CVC-insertion. In the 1-year post CRBSI incidence, mean monthly all-cause inpatient hospitalization costs were $6,015 compared to $2,278 for matched non-CRBSI patients. Similarly, mean monthly total costs were $10,900 (CRBSI) and $6,006 (non-CRBSI). GLM showed per patient per month all-cause inpatient hospitalization, and total costs were significantly higher for CRBSI patients compared to non-CRBSI patients (p<0.05) at 1-year post-CRBSI incidence.

Conclusion: Results suggest that CRBSI patients incur more than double the all-cause inpatient hospitalization costs/month compared to non-CRBSI patients in the year following CRBSI incidence. Total costs for patients were also found to be 83% higher in CRBSI patients as compared to non-CRBSI patients.

ASN Conference

Title: CRBSI Incidence and Associated Mortality Risk: Analysis of Merged USRDS-Medicare Claims

Abstract ID: 3610301

Background: Despite policy and provider initiatives, nearly 80% of end-stage-renal-disease (ESRD) patients initiate hemodialysis (HD) with a central venous catheter (CVC). However, CVCs may elevate risk of catheter hub contamination resulting in catheter-related blood stream infections (CRBSIs) and potentially serious consequences. This analysis aims to estimate the incidence, risk, and associated mortality of CRBSIs among CVC-dependent HD patients in the US.

Method: A propensity score matched case-control analysis of 2013-2017 linked data from the United States Renal Data System (USRDS), dialysis organizations (i.e., CROWNWeb), and Medicare claims was conducted. Occurrence of CRBSI and associated mortality among incident CVC-dependent HD patients between 2014-2016 with a 1-year pre- and ≥1-year post-index were assessed. CRBSI case group index date was the first date of occurrence of either of the following post CVC insertion: ICD-9/10-CM 999.32, T80211x; 999.31, T80219x, T80218x and sepsis/bacteremia diagnosis within ±3 days of hospitalization; sepsis/bacteremia diagnosis without occurrence for pneumonia, gangrene, or urinary tract infections within ±3 days of hospitalization. Non-CRBSI control group was identified by an assigned index date (i.e., CVC insertion date + median days to CRBSI reported in CRBSI-case group). Frequency, mean, median, and chi-square and t-tests assessed group differences. Adjusted cox proportional hazards models examined time to CRBSI and time to mortality post CRBSI.

Results: Of the 55,727 CVC-dependent HD patients (mean age 67.8, 45% female), nearly 29% (n=15,882) developed a CRBSI (median time, 69 days); 54% (n=8,393), 67% (n= 10,327), and 80% (n=12,705) occurred within 90, 180 and 365 days of CVC insertion, respectively. After CRBSI occurrence, 40% and 50% died within 60 days and 180 days, respectively. CRBSI patients also had a significantly lower median survival (25.1 vs. 37.3 months) compared to non-CRBSI patients [hazard ratio: 0.74, 95% CI: 0.71-0.76].

Conclusion: CRBSIs occur in a third of CVC-dependent HD patients, with over half of the initial infections occurring within 90 days of CVC insertion. Patients with CRBSIs had a higher risk of death compared those without CRBSIs with a 40% mortality within 60 days post-CRBSI.

Title: Hospitalization Risk and Long-Term Complications Associated with CRBSI Among Hemodialysis Patients

Abstract ID: 3610389

Background: Central venous catheters (CVC) are frequently required for vascular access in hemodialysis (HD) and are commonly associated with catheter-related bloodstream infections (CRBSIs). CRBSIs may have devastating consequences leading to increased hospitalizations, and long-term complications such as stroke, myocardial infarction (MI), heart failure (HF), and endocarditis, among others. This analysis explores the risk of CRBSI-associated hospitalizations and long-term complications among HD patients.

Method: A 1:1 propensity score matched case-control analysis was conducted using merged data from United States Renal Data System (USRDS), CROWNWeb (dialysis organizations), and Medicare claims database (2013-2017). All CVC-dependent HD patients from 2014-2016 with a 1-year pre- and ≥ 1-year post-index period were included. CRBSI was defined as a composite measure of its ICD codes or sepsis/bacteremia diagnosis with hospitalization or without occurring pneumonia, gangrene, or urinary tract infections and hospitalization. An assigned index date (i.e., CVC insertion date + median days to CRBSI reported in CRBSI-case group) was used to identify non-CRBSI patients. CRBSI/non-CRBSI group differences were described using frequency, mean, median, chi-square, and t-tests. At 1-year post CRBSI, adjusted differences in hospitalizations and hospital days and time to long-term complications were modeled using generalized linear models cox proportional hazard models, respectively.

Results: CRBSIs result in higher 1-year incremental rates of: stroke (6.6%), MI (9.2%), HF (13.4%), PVD (13.6%), and endocarditis (9.4%). Mean number of hospitalizations and hospital days were 3.79 and 25.0 days for CRBSI, and 1.96 and 5.86 days for non-CRBSI patients, respectively. Mean hospitalizations and hospital days were significantly higher for CRBSI vs. non-CRBSI patients (p<0.05) at 1-year post-CRBSI. Hazard ratios for CRBSI patients were stroke (1.64, 95% CI 1.53-1.75), MI (2.56, 95% CI 2.37-2.78), HF (2.01, 95% CI 1.88-2.14), and endocarditis (13.42, 95% CI 10.97-16.42).

Conclusion: Results show HD patients with CRBSIs incur a significant morbidity burden due to increased hospitalizations, hospital days, and long-term complications such as stroke, MI, HF, PVD, and endocarditis.

About CorMedix

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 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 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 from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract manufacturing facility, including in-process controls for the filling operation. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with 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. Neutrolin® is CE Marked and 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, 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 results of our discussions with the FDA regarding the DefenCath development path for marketing authorization; the resources needed to secure approval of the new drug application for DefenCath from the FDA; 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