Merck & Co.'s Long-Delayed Osteoporosis Drug Passes Trial

September 16, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

Biopharmaceutical company Merck & Co., Inc. has announced the results of a Phase 3 fracture outcomes study for osteoporosis drug odanacatib, used in post-menopausal women with osteoporosis.

The data, which was released today, shows that odanacatib met its primary end points in the Long-Term Odanacatib Fracture Trial and reduced the risk of osteoporotic hip, spine and non-vertebral fractures, compared to a placebo.

The results from the trial were presented at the American Society for Bone and Mineral Research Annual Meeting in Houston. The adverse effects of odanacatib were skin lesions and atypical femoral fractures.

“Despite the important and serious consequences of fractures related to osteoporosis and our ability to identify patients who would benefit from therapy, many patients with osteoporosis are not being treated. There is a need for additional treatment options. The effects of odanacatib on fracture risk from the LOFT study are very encouraging,” said Michael McClung, M.D., LOFT leader and founding director of the Oregon Osteoporosis Center, Portland, Oregon.

Compared to patients who received the placebo, those who were given odanacatib had a 47 percent risk reduction of clinical hip fractures and 23 percent risk reduction of non-vertebral fractures.

However, adjudicated atrial fibrillation was reported in 92 percent of patients who received odanacatib in the study. Merck continues to collect data from a blinded extension study.

“Merck believes the currently available data support a favorable benefit/risk profile for odanacatib,” said Dr. Keith Kaufman, vice president, Clinical Research, Diabetes and Endocrinology, Merck. “We want to thank our investigators who conducted the study and the thousands of patients who participated in this study, which is yielding critical insights into the potential of odanacatib in the treatment of postmenopausal osteoporosis.”

In the Long-Term Odanacatib Fracture Trial, more than 16,000 post-menopausal women who had been diagnosed with osteoporosis participated in the study. The trial was a double-blind, placebo-controlled event that included a pre-planned, blinded placebo-controlled extension study. Patients were randomized to receive 50mg of odanacatib per week or the placebo.

Odanacatib works by selectively inhibiting cathepsin K, an enzyme in osteoclast cells that digests proteins during bone resorption.