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Development of CorMedix, Inc.’s (CRMD) Bloodstream Infection Therapy on Pace for Regulatory Approval

Catheter-related bloodstream infections (CRBSIs) are one of the most frequently encountered types of infections contracted in hospital units, resulting in billions of dollars in additional expenses for the U.S. healthcare system every year. It is estimated that there are roughly 250,000 CRBSIs every year, a third of them reported in ICUs. These infections lead to increased hospital stays and higher care costs ranging from approximately $4,000 to $56,000. Additionally, CRBSI cases have an attributable mortality rate of 12% to 25%.

CorMedix Inc. (NYSE: CRMD), a biopharmaceutical company that focuses on developing treatments for infections and inflammatory diseases, is developing a solution to CRBSIs through its innovative lead product, Neutrolin®. The product is an innovative formulation designed to prevent the development of CRBSI, with a focus on patients with central venous catheters. Launched in Germany in 2013 as a Class III drug-device combination to prevent bloodstream infections in hemodialysis patients, Neutrolin® is currently available throughout the European Union, with European Commission approval, but has not yet been approved for use in the United States.

The product has, however, received Fast Track and Qualified Infectious Disease Product designations from the Food and Drug Administration and, as CorMedix recently announced, is currently in phase 3 clinical studies. The company is running one main phase 3 LOCK-IT 100 study analyzing the effects of Neutrolin® on hemodialysis patients, with the goal of completing enrollment by the first quarter of next year and drafting the final data report by the end of the third quarter 2017. A second phase 3 study is being conducted in oncology patients that receive IV parenteral nutrition, hydration and chemotherapy via central venous catheter.

The company is confident that Neutrolin® has the potential to be a game changing product for the prevention of CRBSIs, according to CEO Randy Milby, who stressed the importance of reducing infection rates for all hospitals and dialysis centers both in terms of patient health and the associated economic burden.

He also explained that completing the phase 3 program for the treatment is CorMedix’s top priority and that in anticipates meeting with the FDA to finalize the Neutrolin® protocol before the end of the year.

“Reducing infection rates is a major priority for hospitals and dialysis centers because of the impact infections have on patients as their health is already compromised and cannot risk additional complications. … By reducing infections, Neutrolin is designed to protect both patients and hospitals from catheter-related infections,” he stated in a news release. “Executing on our Neutrolin Phase 3 program, as designed with input from the FDA, is our top priority. LOCK-IT-100 in hemodialysis patients is the first of our two phase 3 clinical studies to support filing for Neutrolin marketing approval. We remain on track with this study and anticipate the DSMB will conduct a safety review in 2016, and with continued progress, we anticipate reporting top-line data in the third quarter of 2017. … We continue our discussions with the FDA to finalize the protocol, at which point we will have achieved an important milestone in our pathway to potential Neutrolin approval.”

In addition, CorMedix announced that it began feasibility testing on a new therapy for pediatric oncology patients with neuroblastoma. CorMedix is working with biopharmaceutical company NanoProteagen Inc. to determine how the latter’s nanoparticle technology, called NanoProTM, will work in combination with CRMD-005, a proprietary formulation designed to target pediatric neuroblastoma.

CorMedix also released its financial data for Q2 2016, reporting a net loss of $4.8 million, or $0.13 per share, primarily attributed to the development and management of the Neutrolin® phase 3 program.

For more information, please visit the company’s website at

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