Crystalgenomics Inc., of Seoul, reported positive findings from its phase III osteoarthritis (OA) study of polmacoxib (formerly CG100649), a next-generation nonsteroidal anti-inflammatory drug. In the six-week efficacy study, polmacoxib 2 mg showed statistically significant superiority over placebo (p = 0.001 at week three, p = 0.011 at week six) and noninferiority compared to celecoxib 200 mg, and patients treated with polmacoxib reported noticeable improvement by week three compared to patients treated with celecoxib. The primary efficacy endpoint was the decrease of pain at week six as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score for polmacoxib vs. celecoxib and placebo in the index joints. Both polmacoxib and celecoxib groups demonstrated significant improvements compared to placebo in most primary and secondary efficacy findings. However, in the WOMAC-physical function at the week three endpoint, only polmacoxib showed statistically significant improvement over placebo (p = 0.003). No drug-related serious adverse events occurred in either treatment group. Crystalgenomics plans to submit a new drug application to the Ministry of Food and Drug Safety during the first half of the year seeking approval of polmacoxib in the osteoarthritis indication.

Idera Pharmaceuticals Inc., of Cambridge, Mass., said it plans to start clinical development of its lead compound, IMO-8400, for the treatment of patients with polymyositis and patients with dermatomysitis, two orphan autoimmune diseases. The company plans to submit a protocol to the FDA in the first half of 2014 for a phase I/II trial to investigate the safety and potential utility of IMO-8400 in those two indications.

Theravance Inc., of South San Francisco, and partner Glaxosmithkline plc, of London, said they completed patient recruitment in the prospective SUMMIT (Study to Understand Mortality and MorbidITy) study, designed to evaluate the impact of Relvar/Breo Ellipta, a combination of fluticasone furoate (FF) and vilanterol (VI), on all-cause mortality among patients with moderate chronic obstructive pulmonary disease (COPD) who also have cardiovascular disease (CVD) or are at increased risk for CVD. The multicenter, double-blind, parallel-group, placebo-controlled study enrolled approximately 16,000 patients, randomized either to once-daily treatment with FF/VI (100/25mcg), FF (100mcg), VI (25mcg) or placebo. Secondary endpoints are rate of decline in forced expiratory volume in 1 second, or FEV1, and a composite CV endpoint. Each patient is expected to participate in the event-driven study for 16 months to 53 months. SUMMIT is the first prospective study to assess whether treatment of COPD will have a positive impact on adverse CV events in patients with both COPD and CVD and/or CV risk factors. (See BioWorld Today, Dec. 9, 2013.)