Merck announced an update on the Phase III trial assessing fracture risk reduction with odanacatib, (a cathepsin K/cat-K inhibitor see structure below). The Data Monitoring Committee (DMC) for the study recently completed its first planned interim analysis for efficacy and recommended that the study be closed early due to robust efficacy and a favorable benefit-risk profile. As a result, Merck will begin taking steps to close the trial. The DMC noted that safety issues remain in certain selected areas and made recommendations with respect to following up on them. Merck's previously announced plan to conduct a blinded extension trial will allow further monitoring of the issues. The extension trial will also continue to measure efficacy.
Merck anticipates submitting regulatory applications for approval of odanacatib in the U.S., European Union (EU) and Japan in the first half of 2013.
"We are encouraged by the Data Monitoring Committee's recommendation to close the trial early," said Peter S. Kim, Ph.D., executive vice president, Merck and president,
Merck Research Laboratories, "and look forward to reviewing the data with the scientific community to bring forward this innovation."
The Phase III randomized, placebo-controlled trial with over 16,000 patients was designed to assess the safety and efficacy of odanacatib in reducing fracture risk in post-menopausal women with osteoporosis. This event-driven trial started in 2007 and was expected to continue until hip fractures had been reported in a total of 237 patients. The interim analysis was conducted by the DMC as planned when approximately 70 percent of the targeted number of hip fractures had been reported.
Merck expects the process of closing this large, multi-center trial to take a number of months. Trial investigators will schedule final assessments for trial participants at 387 sites in 40 countries. Data from these visits will be collected and reviewed to allow a full and complete analysis, and final results of the study will be submitted for presentation and publication in 2013 once the analysis is complete.
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