ARTICLE | Clinical News

DP-b99: Phase I data

August 30, 2010 7:00 AM UTC

Top-line data from a crossover, double-blind Phase I cardiac safety trial in 32 healthy volunteers showed that 1 and 3 mg/kg doses of DP-b99 had no effect on the QT segment of an electrocardiogram compared to the positive control moxifloxacin, which prolonged the QTc interval. In April, D-Pharm received an SPA from FDA for the Phase III MACSI trial of DP-b99 for the indication. Data from MACSI are expected late next year. ...