Polmacoxib: Phase III data
A double-blind, South Korean Phase III trial in 362 patients ages >=20 with OA of the knee or hip showed that once-daily 2 mg oral polmacoxib was non-inferior to once-daily 200 mg celecoxib and superior to placebo (p=0.011) on the primary endpoint of improving WOMAC pain score in the index joints from baseline to week 6. Polmacoxib also significantly reduced WOMAC pain score from baseline to week 3 vs. placebo (p=0.001). CrystalGenomics said that both polmacoxib and celecoxib showed significant improvements vs. placebo on all primary and secondary endpoints at weeks 3 and 6, except for WOMAC physical function score. On the secondary endpoint of change from baseline to week 3 in WOMAC physical function score, polmacoxib led to a significant improvement over placebo (p=0.003), but celecoxib did not (p=0.069).
On other secondary endpoints, the proportion of patients whose condition was "much improved" by week 3 based on SGA score was 18.5% in the polmacoxib arm and 12.4% in the celecoxib arm vs. 2.8% for placebo. The proportion of patients whose condition was "much improved" by week 3 based on PGA score was 21% in the polmacoxib arm and 15.2% in the celecoxib arm vs. 4.2% for placebo. There were no treatment-related serious adverse events in either polmacoxib or celecoxib arm and no significant difference in adverse events between all 3 arms. This half, CrystalGenomics plans to submit an NDA to South Korea's Ministry of Food and Drug Safety (MFDS) for polmacoxib to treat OA. ...