CorMedix Inc., of Bridgewater, N.J., reported an interim analysis of a Phase II study of CRMD001 (deferiprone) in preventing contrast-induced acute kidney injury (CI-AKI) in high-risk patients who have chronic kidney disease. CRMD001 appears to have a favorable safety profile, according to a blinded review of the data. So far, 38 patients have been enrolled at six U.S. sites, with five reported serious adverse events that are not considered to be drug-related. The company plans to enroll a total of 60 patients by midyear, with final results available in the second half of the year. The study is evaluating the effect of CRMD001 on kidney function and acute kidney injury by measuring changes from baseline in several biomarkers. No therapy has been approved for that indication.
Intercell AG, of Vienna, Austria, hopes to start a confirmatory efficacy trial early next year of its investigational Pseudomonas aeruginosa vaccine in ventilated intensive care unit patients, as part of its strategic alliance with Novartis AG, of Basel, Switzerland. The planned double-blind study is powered to show a clinically meaningful and statistically significant reduction in overall mortality. The trial, subject to final regulatory approval, would enroll about 800 subjects at 50 sites, mostly in Europe. Intercell will execute the trial, and the costs will be shared with Novartis.