CorMedix Inc. is a commercial-stage biopharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases. The Company received IND approval from the U.S. Food and Drug Administration (FDA) to proceed with a pivotal Phase 3 multi-center clinical trial for Neutrolin® in hemodialysis patients with central venous catheters.
Phase 2b clinical trial in ICU-critical care for label expansion.
Neutrolin® (CRMD-003) has CE mark approval for use in the European Union, but is not approved in the United States.
Neutrolin® is a novel formulation of Taurolidine 3.5% Citrate 3.5% and Heparin 1000 units/mL that provides a preventative solution, which decreases the triple threat of infection, thrombosis and biofilm formation as a catheter lock solution; thereby keeping central venous & peripherally inserted catheters operating safely and efficiently by optimizing catheter blood flow while minimizing infections and biofilm formation for oncology, hemodialysis, and intensive care patients. Taurolidine is an amino acid derivative which is an antibacterial and shows broad antibacterial action against gram-positive and gram-negative bacteria, mycobacteria and clinically relevant fungi. Central venous catheters and peripherally inserted central catheters are an important and frequently used method for accessing the vasculature in hemodialysis (a form of dialysis where the patient's blood is circulated through a dialysis filter), administering chemotherapy and basic fluids (total parenteral nutrition) in cancer patients and for cancer chemotherapy, long term antibiotic therapy, total parenteral nutrition (complete or partial dietary support via intravenous nutrients) and critical care/intensive care patientbiofilm with microbial colonization develops within 24 hours after CVC placement.
Currently, there are no pharmacological agents approved in the United States for the treatment of catheter related bloodstream infections.
**** De-Risked**** Phase 3 Neutrolin US Clinical Trial:
Data from the NUMP (Neutrolin Usage Monitoring Program) European Union Post-Approval Surveillance Study significantly exceeds the FDA threshold of 40% reduction rate for the Phase 3 study with No Reported Human Resistance, Significantly Reduces the Rates of Infection and Thrombosis in Hemodialysis Patients Enrolled in a Post-Approval Surveillance Study. This European Post-Approval Surveillance Study data continues to improve AND impress.
(See updated Slide# 7 on the Corporate Overview Slide Presentation - at the bottom of the web page link above)
Since May 30, 2015, when last released, the updated NUMP data reveals the following:
Efficacy shows IMPROVEMENT!!! (97% REDUCTION in INFECTIONS AND 97% REDUCTION in THROMBOSES) with NO reported cases of Human Resistance.
- # Catheter Days: 29,253 (38% INCREASE - Previously: 21,151 catheter days)
- # Patients: 142 (18% INCREASE - Previously: 120 patients)
- Infections: 3 (Previously 3 - NOW representing a 97.1% REDUCTION vs. benchmark - Previously: 96%)
- Thromboses: 2 (Previously 2 - NOW representing 97.2% REDUCTION vs.benchmark - Previously: 96%)
**** Bottom Line: Continued (improvement in) Significant Data Supportive of De-Risking Phase 3 Clinical Trial!!
Disclosure: I am/we are long CRMD.
Additional disclosure: I am long this security, CRMD. This piece was written solely by me and the views and opinions written and expressed in this piece are are solely this author's. I have NOT received any type of compensation for authoring this piece, and I have NO business relationship with any company or stock mentioned in this piece.