New NSAID Polmacoxib Shows Promise in OA Patients
Phase III trial demonstrates non-inferiority to celecoxib
Positive results have been reported from a phase III clinical trial of polmacoxib (formerly CG100649), an investigational nonsteroidal anti-inflammatory drug (NSAID), in patients with osteoarthritis (OA). Polmacoxib is being developed by a Korean company, CrystalGenomics.
The new study was a double-blind, randomized, active- and placebo-controlled trial designed to evaluate the safety and efficacy of polmacoxib 2 mg versus placebo and celecoxib 200 mg in 362 subjects with OA. Of these subjects, 146 received polmacoxib 2 mg; 145 received celecoxib 200 mg; and 71 received placebo. The subjects’ median age was 63 years (range, 28 to 83 years), and most (85%) were women.
The study’s primary efficacy endpoint was the decrease in pain at week 6, as measured by the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain score, for polmacoxib versus celecoxib and placebo in the index joints.
In this study, polmacoxib 2 mg showed statistically significant superiority over placebo at both week 3 (P = 0.001) and week 6 (P = 0.011). The treatment also demonstrated non-inferiority to celecoxib 200 mg; patients treated with polmacoxib reported noticeable improvement by week 3 compared with those treated with celecoxib.
Based on all of the primary and secondary efficacy parameters at week 3 and week 6, other than the WOMAC–Physical Function score, both the polmacoxib and celecoxib groups demonstrated significant improvements compared with the placebo group. However, in the WOMAC–Physical Function assessment at week 3, only polmacoxib showed statistically significant improvement over placebo (P = 0.003). The difference between celecoxib and placebo was not statistically significant (P = 0.069).
Based on the Subject’s Global Assessment, approximately 18.5% of subjects in the polmacoxib group and 12.4% of subjects in the celecoxib group reported their condition as “much improved” by week 3 compared with 2.8% of the subjects in the placebo group. For the Physician’s Global Assessment, approximately 21% of subjects in the polmacoxib group and 15.2% of subjects in the celecoxib group were considered by the investigator to be much improved by week 3 compared with 4.2% of subjects in the placebo group.
No drug-related serious adverse events occurred in either the polmacoxib or celecoxib treatment group. Most of the adverse events were mild to moderate in severity.
Source: PipelineReview; March 13, 2014.