Ampion: Phase III data

Top-line data from the double-blind Phase III SPRING trial in 329 patients showed that single intra-articular injections of Ampion met the primary endpoint of reducing pain as measured by WOMAC-A scores from baseline to 12 weeks vs. saline vehicle control (p=0.0038). Ampion led to >40% average reduction in pain from baseline. Additionally, Ampion met the secondary endpoints of improving function as measured by WOMAC-C scores (p=0.044) and overall quality of life as measured by PGA scores (p=0.012) from baseline to 12 weeks vs. saline control. Ampio said there were no significant differences in efficacy between the 4 and 10 mL doses of Ampion. Ampion was well tolerated, with no treatment-related serious adverse events reported. ...