SEOUL, KOREA, March 13, 2014 - CrystalGenomics, Inc., a clinical stage biopharmaceutical company developing novel therapeutics in high unmet disease areas has announced positive results from its Phase 3 osteoarthritis (OA) clinical study of polmacoxib (formerly CG100649), a next-generation NSAID.
Based on the overall results of the 6-week efficacy study, polmacoxib 2 mg showed statistically significant superiority over placebo (p-value=0.001 at Week 3; p-value=0.011 at Week 6) and non-inferiority compared to celecoxib 200 mg, and patients treated with polmacoxib reported noticeable improvement by week 3 compared to patients treated with celecoxib.
The primary efficacy endpoint was the decrease of pain at Week 6 as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain score for polmacoxib versus celecoxib and placebo in the index joints.
Based on all primary and secondary efficacy parameters at Week 3 and 6 other than WOMAC-Physical Function, both polmacoxib and celecoxib groups demonstrated significant improvements compared to placebo. However, in the WOMAC-Physical Function at Week 3 endpoint, only polmacoxib showed statistically significant improvement over placebo (p = 0.003) as celecoxib had failed to show statistically significant improvement over placebo (p =0.069).
Based on the Subject’s Global Assessment, about 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 to 2.8% of subjects in the placebo group. For the Physician’s Global Assessment, about 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 to 4.2% of subjects in the placebo group.
There were no drug-related serious adverse events in either of the polmacoxib or celecoxib treatment groups. Most of the adverse events were mild to moderate and were expected to happen in this type of trial. There were no statistically significant differences in all three groups.
Dr. Seonggu Ro, EVP & CTO of CrystalGenomics, stated, “Based on all scores of WOMAC subscales at both Week 3 and Week 6, there was a clear tendency of earlier noticeable improvement in patients treated with polmacoxib in terms of relief of pain, stiffness, and daily physical function.”
Dr. Joong Myung Cho, President & CEO of CrystalGenomics, stated, “This is an important milestone for CrystalGenomics as we have taken another step closer towards our mission to provide a new drug for the osteoarthritis patients to help alleviate their sufferings and other associated symptoms. Based on the success of the Phase 3 clinical trial of polmacoxib, we expect to submit a New Drug Application (NDA) to the Ministry of Food and Drug Safety (MFDS) within the first half of this year for an approval of the osteoarthritis indication.”
About the Polmacoxib Phase 3 Osteoarthritis Clinical Trial
This Phase 3 efficacy trial was a double-blind, randomized, multicenter, active- and placebo-controlled study that randomized 362 subjects with osteoarthritis to evaluate the safety and efficacy of polmacoxib 2 mg vs. placebo and celecoxib 200 mg. Among 362 subjects, 146 were administered with polmacoxib 2 mg, 145 with celecoxib 200 mg, and 71 with placebo. There were 53 males (15%) and 309 females (85%). The average age was 62.4 with median age of 63 and the range was 28 to 83. The trial was conducted in 14 university/research hospitals in Seoul and southern parts of the country.
About CrystalGenomics
CrystalGenomics Inc. is a clinical stage biopharmaceutical company focused in the discovery and development of novel drugs in therapeutic areas of unmet medical needs including inflammation, oncology and infectious disease. For more information on CrystalGenomics, please visit: www.cgxinc.com.
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