Cormedix Inc. Announces Presentation at Conference Showing Mortality Risk and Complications in Patients Experiencing Catheter Related Blood Stream Infections

Rhea-AI Summary

CorMedix Inc. (Nasdaq: CRMD) announced a poster presentation at the ASHP conference highlighting a study of kidney failure patients on hemodialysis with central venous catheters. Of 51,161 patients studied, 33% developed catheter-related bloodstream infections (CRBSIs), significantly increasing mortality rates and long-term complications. Patients with CRBSIs had a 30-day mortality rate of 10.8% compared to 2.0% for others. CorMedix aims to address this challenge with its product, DefenCath, which has shown the potential to reduce CRBSIs by approximately 71% in clinical studies.

Positive

• DefenCath demonstrated a potential 71% reduction in CRBSI incidents in a Phase III study.
• The company is actively pursuing marketing authorization for DefenCath in 2023.

Negative

• CorMedix received multiple Complete Response Letters from the FDA regarding its NDA for DefenCath, indicating unresolved deficiencies.
• The dependence on contract manufacturing organizations and suppliers for heparin introduces risk in the approval process.

BERKELEY HEIGHTS, N.J., Dec. 06, 2022 (GLOBE NEWSWIRE) -- 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 the abstract publication and poster presentation at the American Society of Health-System Pharmacists (ASHP) conference in Las Vegas, Nevada, December 4 – 8.

The abstract being presented highlights research that was conducted by integrating multiple clinical and claims databases that track a large cohort of kidney failure patients on hemodialysis (HD) with central venous catheters (CVCs). The conclusions from this retrospective study further underscore the significant mortality risk and long-term complications associated with catheter-related bloodstream infections (CRBSIs). The data show that of the 51,161 CVC-HD patients studied, approximately 33% of patients initiated on HD with a CVC experience a CRBSI. Other findings include:

• Patients with CRBSIs had five times higher 30-day mortality rates (10.8%) vs. non-CRBSIs patients (2.0%), as well as higher mortality rates seen at 90 days, 180 days and 1 year.
• Patients with CRBSI also experienced higher rates of long-term complications including Stroke, Peripheral Vascular Disease, Myocardial Infarction, Heart Failure, and had generally longer and more complicated hospital courses.
• Of diagnosed CRBSIs, 33% and 47% were developed within 30- and 90- days post-CVC insertion, respectively.
  

Joseph Todisco, Chief Executive Officer of CorMedix commented, “The data being presented represent a continuation of the work by the CorMedix team to highlight the magnitude and severity of CRBSIs as a serious and frequent problem faced by the hemodialysis patient community. CorMedix is working to address this unmet medical need and has demonstrated in a large Phase III clinical study that DefenCath can reduce the incidence of CRBSIs in patients undergoing hemodialysis via CVC by approximately 71% with a good safety profile. CorMedix remains steadfast in our efforts to obtain marketing authorization and bring DefenCath to patients in 2023.”

The abstract accepted for presentation is included below.

ASHP Conference

Title: Mortality Risk and Long-Term Complications Associated with Cather-Related Bloodstream Infections (CRBSIs)
Abstract ID: 1293398

Purpose: Despite many initiatives to improve kidney health over two decades, kidney failure patients on hemodialysis (HD) with central venous catheters (CVCs) are at increased risk of catheter-related bloodstream infections (CRBSIs). To date, CRBSIs remain a preventable complication of CVC-dependent HD (CVC-HD) with high morbidity and mortality resulting from long-term complications (LTCs). This analysis builds on prior research to utilize a claims-based algorithm to assess the incremental real-world clinical burden of CRBSIs in inpatient/outpatient (IP/OP) settings among CVC-HD patients.

Methods: A retrospective propensity score-matched analysis of 2013-2018 linked data from the United States Renal Data System (USRDS), CROWNWeb (dialysis organizations), and Medicare claims was conducted. Occurrence of CRBSI, LTCs (e.g., stroke, peripheral vascular disease (PVD), myocardial infarction (MI), and heart failure (HF)) as well as 30-day, 90-day, 180-day, and 365-day mortality among incident CVC-HD patients between 2014-2017 with 1-year pre- and ≥ 1-year post-index data were assessed. Incidence of CRBSI was defined as the first date of inpatient (IP)/ outpatient (OP) CRBSI occurrence. IP CRBSI was defined as 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, whereas OP CRBSI was defined as the first oral/intravenous antibiotic prescription within ±1 day of the first OP emergency/urgent care visit post-CVC insertion. CRBSI/non-CRBSI group differences were described using frequency, mean, median, chi-square tests, t-tests, Cramer’s V, and Wilcoxon-Rank Sum tests as appropriate. Cox proportional hazards models were used to examine the associations between CRBSI and mortality and LTCs.

Results: Of the 51,161 CVC-HD patients (mean age 63 years, 47% female) nearly 33% developed a CRBSI (median time, 107 days), out of which 81% (n=13,559) were diagnosed IP and 19% (n=3,254) were diagnosed in OP settings. Of the patients with CRBSIs, 33% and 47% developed it within 30- and 90- days post-CVC insertion. Five times higher 30-day mortality rates were reported among patients with CRBSIs (10.8%) vs. non-CRBSIs (2.0%). Mortality rates at 90, 180, and 365 days after CRBSI occurrence was 19.2% (n=2,858), 26.6% (n=3,961), and 35.9% (n=5,351) in CRBSI patients and 5.2% (n=770), 9.2% (n=1,358), and 15.7% (n=2,344) in non-CRBSI patients, respectively. Annual LTC rates between patients with CRBSIs vs. non-CRBSIs were 16.6% vs. 10.4% for stroke, 40.8% vs. 29.8% for PVD, 13.3% vs. 8.2% for MI, and 58.1% vs. 42.4% for HF, respectively. Hazard ratios for CRBSI patients were stroke (1.47, 95% CI 1.38-1.56), PVD (1.49, 95% CI 1.43-1.55), MI (1.52, 95% CI 1.42-1.64), HF (1.66, 95% CI 1.61-1.71).

Conclusion: In this study of CVC-HD patients in the US, 1 in 3 patients developed CRBSIs in total; 33% and 47% developed within 30- and 90-days of CVC insertion. Patients with CRBSI had 1-year mortality rates of 36% with incremental mortality nearly five times greater among CRBSI patients within 30 days from the initial infection. The high magnitude of morbidity and mortality burden associated with CRBSIs underscores the importance of early intervention to prevent CRBSIs among kidney failure patients with CVC-HD.

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 facility deficiencies identified during a pre-approval inspection at and conveyed to the CMO and during an inspection for an unrelated active pharmaceutical ingredient at and conveyed to the manufacturing facility for the heparin supplier for DefenCath. While the CMO and heparin supplier work to resolve outstanding deficiencies, CorMedix is simultaneously working to transfer the technology to an additional CMO and qualify an additional supplier of heparin. 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. 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 future financial position, financing plans, future revenues, projected costs and the sufficiency of our cash and short-term investments to fund our operations 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 and secure final FDA approval prior; the ability to 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 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

FAQ

What were the findings of the CorMedix study on CRBSIs presented at the ASHP conference?

The study found that 33% of kidney failure patients on hemodialysis with central venous catheters developed CRBSIs, which significantly increased mortality rates and long-term complications.

What is CorMedix's strategy for addressing catheter-related bloodstream infections?

CorMedix aims to address CRBSIs with its product DefenCath, which has shown a potential 71% reduction in infections in clinical studies.

When does CorMedix plan to submit its NDA for DefenCath?

CorMedix is working to obtain marketing authorization for DefenCath and aims to submit its NDA in 2023.

What are the mortality rates for patients with CRBSIs according to the CorMedix study?

Patients with CRBSIs had a 30-day mortality rate of 10.8%, which is five times higher than the 2.0% rate for non-CRBSI patients.

What were the complications associated with CRBSIs found in the study?

Patients with CRBSIs experienced higher rates of long-term complications such as stroke, myocardial infarction, and heart failure.