Summary
- Candidate could get approval.
- But IP not very strong.
- Not enough funds for development pipeline.
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CorMedix Inc. (NYSEMKT:CRMD) is a commercial-stage biopharmaceutical company, focused on therapeutic products for the prevention and treatment of infectious and inflammatory diseases in the United States and internationally. Its lead product candidate Defencath, marketed in Europe and other territories as Neutrolin, a CE-marked medical device, is an antimicrobial and antifungal solution designed to prevent catheter-related bloodstream infections ("CRBSIs") in patients with end-stage renal disease ("ESRD") receiving hemodialysis ("HD") through a central venous catheter ("CVC").
Catalyst
The company recently submitted a New Drug Application ("NDA") for Defencath to the U.S. Food and Drug Administration ("FDA"). The drug having Fast Track and Qualified Infectious Disease Product Designations has been granted priority review by the FDA with a Prescription Drug User Fee Act ("PDUFA") goal date of 2/28/2021.
The Product
Defencath is a proprietary formulation of taurolidine 1.35%, citrate 3.5% and heparin 1,000 units/mL to reduce the risk of infections from in-dwelling catheters. The key compound in Defencath, taurolidine, is an amino acid derivative with in-vitro studies indicating broad antimicrobial activity against gram-positive and gram-negative bacteria, including antibiotic resistant strains, as well as mycobacteria and clinically relevant fungi including Aspergillus.
CorMedix is researching to leverage its taurolidine technology for developing a pipeline of antimicrobial medical devices. Research programs are active 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.
Trial
CorMedix completed its Phase 3 clinical study of Defencath, known as LOCK-IT-100. The primary objective of the randomized, double-blind, active control, parallel-arm, clinical trial was to demonstrate the efficacy and safety of Defencath as a catheter lock solution ("CLS") for prevention of CRBSI in subjects receiving HD for the treatment of ESRD when compared with heparin. The trial was terminated in August 2018 following the recommendation of the independent Data Safety Monitoring Board (DSMB), because efficacy had been demonstrated and the pre-specified level of statistical significance had been achieved with no safety concerns. CorMedix announced the top-line results from the interim analysis of the study in January 2019 with efficacy data from 653 subjects at the time of the interim analysis, including the first 28 cases of CRBSI. The study continued enrolling and treating subjects until study termination, so the final efficacy analysis was based on a total of 795 subjects.
