Phase II success for odanacatib (Merck Inc.) for Post Menopausal Osteoporosis

Merck Inc., has announced results from a Phase II trial for odanacatib, an investigational cathepsin K (cat-K) inhibitor in development for the treatment of Osteoporosis in post-menopausal women. The results were presented at the 34th Annual Meeting of the American Society for Bone and Mineral Research.

In the study, treatment with odanacatib (compared to placebo) significantly increased Bone Mineral Density (BMD) over a two-year period in post-menopausal osteoporotic women who previously had three or more years of treatment with alendronate. This study was a randomized, double-blind, placebo-controlled, multi-center, 24-month trial of odanacatib in 243 women. In the odanacatib group, BMD changes from baseline at 24 months were significantly different versus placebo at all three hip sites, and the lumbar spine. At the distal forearm, BMD changes from baseline at 24 months were -0.92% and -1.14%. The difference versus placebo at the distal forearm (+0.22%) was not statistically significant. The overall incidence of adverse events, including those that were considered drug-related or serious, were similar between treatment groups.