AZX100: Final Phase IIa data

Final data from the double-blind Phase IIa OL-ASCAR-03 trial in 146 patients showed that 3 and 10 mg intradermal AZX100 administered 9 and 21 days following arthroscopic shoulder surgery missed the primary endpoint of significantly improving POSAS scores from baseline to 12 months vs. placebo. Capstone also said that low- and high-dose AZX100 showed no meaningful benefit on the secondary endpoints of monthly POSAS and VAS scores at 12 months vs. placebo. At 3 months, patients treated with either dose of AZX100 had significantly smaller scars as measured by total volume vs. placebo (p=0.0094 and p=0.033, respectively). However, the improvements were not maintained at month 12 (p=0.56 and p=0.66, respectively). Furthermore, an analysis of scar histology at 12 months, which measured collagen density, maturity and orientation, showed that low-dose AZX100 led to significant or near-significant improvements in all 3 measures vs. placebo. No improvements were observed for the 10 mg dose in the scar histology analysis. ...