Merck announced results from the Phase 3 LOFT study with odanacatib in postmenopausal women with osteoporosis. Odanacatib selectively inhibits cathepsin K, the primary enzyme in the osteoclasts that digests proteins during bone resorption.
The Long-Term Odanacatib Fracture Trial (LOFT) is a randomized, double-blind, placebo-controlled, event-driven trial, including a pre-planned, blinded placebo-controlled extension study. The trial enrolled 16,713 women, ≥65 years of age, diagnosed with osteoporosis, who have been postmenopausal for five years or more. Patients were randomized to receive odanacatib 50mg/week (n=8,357) or placebo (n=8,356). All patients received vitamin D (5600IU/week) and calcium up to 1200mg/day, if required.
Odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. Compared to patients receiving placebo, patients who received odanacatib had a 54% relative risk reduction of new and worsening morphometric (radiographically-assessed) vertebral fractures (P<0.001), a 47% relative risk reduction of clinical hip fractures (P<0.001), a 23% relative risk reduction of clinical non-vertebral fractures (P<0.001), and a 72% relative risk reduction of clinical vertebral fractures (P<0.001).
Treatment with odanacatib also led to progressive increases over five years in bone mineral density (BMD) at the lumbar spine and total hip. Compared to placebo, the change in BMD from baseline at five years with odanacatib for lumbar spine was 11.2% (P<0.001) and for total hip was 9.5% (P<0.001).
Merck plans to submit a New Drug Application (NDA) to the FDA for odanacatib in 2015.
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