CorMedix (NASDAQ:CRMD) said on Wednesday morning that an independent Data Safety Monitoring Board (DSMB) has finished its review of the interim analysis of data collected during the biopharmaceutical company's late-stage clinical trial of Neutrolin to prevent catheter-related blood stream infections (CRBSIs) in patients receiving hemodialysis for end-stage renal disease.
The DSMB delivered the type of news the New Jersey-based company wanted to hear, recommending the phase 3 trial be terminated early based upon the data meeting its key endpoints already.
In addition to primary endpoint of reducing risk of infection, the secondary endpoints were catheter patency, which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction, and catheter removal for any reason.
In the study, dubbed LOCK-IT-100, Neutrolin, a catheter lock solution (consisting of taurolidine 1.35%, citrate 3.5% and heparin 1000 units/mL), safely demonstrated a statistically significant improvement in preventing the occurrence of CRBSIs in patients on hemodialysis for kidney disease compared to heparin.
Neutrolin is a non-antibiotic anti-infective developed by CorMedix as a preventative solution to decrease the threat of infection and thrombosis, thereby keeping central venous catheters operating safely and efficiently.
Per clinicaltrials.gov, the trial, which begain 2-1/2 years ago, was slated to enroll 632 adults.
Now that the DSMB has said to conclude the study, CorMedix plans to submit the results of the interim analysis to the FDA for its review. The company will look to add an FDA approval to its CE Mark in Europe that allows Neutrolin to be marketed as a medical device. In post-market studies, Neutrolin was shown to reduce CRBSIs by 96% and blood clots by 96.7% compared to historical benchmarks.
After closing at 28 cents on Tuesday, shares of CRMD shot ahead to open today at 33 cents and ran as high as 45 cents, which was the highest for the stock since February 20. By the end of the day, though, CRMD gave up part of the gains, closing at 33 cents for a gain of 16.4%.
