CorMedix
CorMedix Inc. (CRMD) and Subsidiary, is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases.
The company's primary focus is to develop its lead product candidate, Neutrolin® (also known as CRMD003), for potential commercialization in the U.S. and other key markets. CorMedix has in-licensed the worldwide rights to develop and commercialize Neutrolin, which is a novel anti-infective solution (a formulation of taurolidine, citrate and heparin 1000 u/ml) under development in the U.S. for the reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters in clinical settings such as dialysis, critical/intensive care, and oncology. Infection and thrombosis represent key complications among critical care/ intensive care and cancer patients with central venous catheters. These complications can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the central venous catheter, related treatment costs and increased mortality. The company believe Neutrolin has the potential to address a significant unmet medical need and represents a potential large market opportunity.1
The company initiated one Phase 3 clinical trial in hemodialysis patients with a central venous catheter (“LOCK-IT-100”) in December 2015. Two pivotal trials to demonstrate safety and effectiveness of Neutrolin are required by the U.S. Food and Drug Administration (“FDA”) to secure marketing approval in the United States. Based on its experience in the LOCK-IT-100 trial, CorMedix is reassessing the structure of its planned second Phase 3 clinical trial to seek efficiencies and improvements in the design and execution. This reassessment is expected to be completed in the next several months.
In April 2017, a safety review by an independent Data and Safety Monitoring Board, or DSMB was completed. The DSMB unanimously concluded that it is safe to continue the LOCK-IT-100 clinical trial as designed based on its evaluation of data from the first 279 patients randomized on trial.
On August 2, 2017, the company announced that the FDA had agreed to key changes to the LOCK-IT-100 clinical trial. The company believe that the changes endorsed by the FDA facilitate its ability to complete the ongoing Phase 3 clinical trial in hemodialysis patients with central venous catheters, as previously announced, by year-end 2018. The company sought guidance from the FDA to address, in part, the apparent overall lower rate of catheter-related blood stream infection (CRBSI) events as announced in April 2017. Changes made to the protocol were 1) the utilization of a Clinical Adjudication Committee (CAC) to assess suspected CRBSIs; 2) the use of the CAC to critically and independently assess suspected CRBSIs in a blinded fashion based on a single positive blood culture and supporting documentation, rather than two positive blood cultures as currently required; 3) the ability to capture cases occurring outside of dialysis centers to facilitate more complete capture of CRBSI events in the study, particularly when patients present with CRBSI events outside of the dialysis center setting (emergency rooms or urgent care centers); and 4) a revision of the design of the study to detect a treatment effect of 55% or greater when comparing the Neutrolin and heparin control arms. The FDA agreed that cases adjudicated by the CAC to be CRBSI events and the per protocol definition of CRBSI events will be included in the primary analysis of the primary efficacy endpoint of the LOCK-IT-100 study. The amended study assumptions including a reduction in statistical power have resulted in a reduction in the total number of CRBSI events required from 161 events to 56 events to complete the study.
The company believe that these changes will allow the identification of more infections, enabling a single interim analysis, which is anticipated to occur in the fourth quarter of 2017 based on 28 CRBSI events. Should the interim analysis show sufficient efficacy it may be possible to conclude the study earlier than projected. Further, based on its experience in the LOCK-IT-100 trial, CorMedix is reassessing the structure of its planned second Phase 3 clinical trial to seek efficiencies and improvements in its design and execution. This reassessment is expected to be completed in the next several months.
In July 2013, the company received CE Mark approval for Neutrolin. As a result, in December 2013, the company commercially launched Neutrolin in Germany for the prevention of catheter-related bloodstream infections and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. To date, Neutrolin is registered and may be sold in certain European Union and Middle Eastern countries for such treatment. In April 2017, the company entered into a commercial collaboration with Hemotech SAS covering France and French overseas territories.
CorMedix is evaluating opportunities for the possible expansion of taurolidine as a platform compound for use in certain medical devices. Patent applications have been filed in wound closure, surgical meshes, wound management, and osteoarthritis, including visco-supplementation. Based on initial feasibility work, CorMedix is advancing preclinical studies for three product candidates: surgical meshes, suture materials, and hydrogels. There exists a need to control and protect against surgical site infections upon wound closure and the company believe taurolidine may provide benefits not currently available in marketed antimicrobial medical devices. It may also provide a significant advantage in devices for burn victims and use in less sterile environments. The company expect to develop and pursue FDA clearance for these potential products by the 510(k) pathway and will seek to establish development/commercial partnerships as these programs advance. CorMedix is also involved in a pre-clinical research collaboration for the use of taurolidine as a possible combination treatment for rare orphan pediatric tumors.
Since its inception, CorMedix has not generated sufficient revenue from product sales to be profitable. The company's operations to date have been primarily limited to conducting clinical trials for its product candidates, establishing manufacturing for its product candidates, licensing product candidates, performing business and financial planning, performing research and development, seeking regulatory approval for its products, initial commercialization activities for Neutrolin in the European Union and other foreign markets, and maintaining and improving its patent portfolio. CorMedix has funded its operations primarily through debt and equity financings. CorMedix has generated significant losses to date, and the company expect to use substantial amounts of cash for its operations as the company continue to conduct its ongoing Phase 3 clinical trial in hemodialysis patients with catheters, commercialize Neutrolin in the European Union and other foreign markets, pursue business development activities, incur additional legal costs to defend its intellectual property, and seek FDA approval of Neutrolin in the U.S. As of June 30, 2017, the company had an accumulated deficit of approximately $131.9 million. CorMedix is unable to predict the extent of any future losses or when the company will become profitable, if ever.
