New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada. The data from clinical and preclinical studies, presented in two oral presentations and six posters, continue to provide further background on the potential of odanacatib to increase bone density, cortical thickness and bone strength when treating osteoporosis.
“What are the possible side effects of FOSAMAX?”
"We are pleased to be able to have such a robust presentation of new data for odanacatib at the 2010 ASBMR Annual Meeting," said Albert Leung, M.D., Ph.D., executive director, Clinical Research, Merck Research Laboratories. "The clinical and preclinical data being presented show long-term increase in bone mineral density and impact on bone formation with odanacatib therapy. We are continuing our strong and long-standing commitment to the field of osteoporosis with a large and rigorous Phase III program to evaluate the long-term efficacy and safety of odanacatib."
Odanacatib is a cathepsin-K inhibitor that selectively inhibits the cathepsin-K enzyme. Cathepsin-K is known to play a central role in the function of osteoclasts, which are cells that break down existing bone tissue, particularly the protein components of bone. Inhibition of cathepsin-K is a novel approach to the treatment of osteoporosis. Odanacatib is currently in Phase III clinical trials and is being evaluated in a large-scale clinical study to determine potential effects on vertebral, hip and non-vertebral fractures.
Following are highlights from four of the eight presentations at ASBMR. Abstracts can be viewed by visiting the ASBMR website at www.ASBMR.org.
Abstract # 1247; Oral Session 42, October 18, 2010 4:30 PM - 4:45 PM ET - Effect of Odanacatib on Bone Density and Bone Turnover Markers in Postmenopausal Women with Low Bone Mineral Density: Year 4 Results
In a Phase IIb clinical study odanacatib reduced bone resorption markers and progressively increased bone mineral density (BMD) during four years of treatment. A two-year base study of postmenopausal women with low bone mass (BMD T-scores between -2.0 and -3.5 at the lumbar spine, femoral neck, trochanter or total hip) was extended for two additional years.
In postmenopausal women who received odanacatib 50 mg weekly for four years.
Abstract # FR0435; Plenary Poster Session, October 15, 2010 5:45 PM - 7:00 PM ET - A Multi-Modality Imaging Comparison of Odanacatib to Alendronate in the Ovariectomized Rhesus Monkey
This preclinical analysis was designed to evaluate the efficacy of the cathepsin-K inhibitor odanacatib compared to alendronate in the estrogen-deficient model of the ovariectomized rhesus monkeys.
Abstract # FR0440; Plenary Poster Session, October 15, 5:45 PM - 7:00 PM ET - Quantitative Computed Tomography Based Finite Element Analysis to Estimate In-Vivo Bone Strength of Proximal Femur in Odanacatib Treated Rhesus Monkeys
This preclinical analysis was designed to examine in-vivo estimates of bone strength in the proximal femur in ovariectomized rhesus monkeys.
Abstract # SA0437; Poster Session I, October 16, 2010 11:30 AM - 1:30 PM ET - Differential Effects of Odanacatib Compared to Alendronate on Bone Turnover Markers in Adult Ovariectomized Rhesus Monkeys
This preclinical analysis in ovariectomized rhesus monkeys.
Additional Studies
Other studies presented by Merck on odanacatib at ASBMR include:
- Abstract # SU0250 - Effects of Odanacatib Treatment on Osteoclast Vesicular Trafficking During Bone Resorption
- Abstract # SU0438 - Lack of Intermittent PTH Response to Daily Administration of Odanacatib in Adult-Ovariectomized Rhesus Monkeys
- Abstract #1171 - Comparing the Effects of Odanacatib versus Alendronate on Bone Turnover of Transilial Biopsy in Adult Ovariectomized Rhesus Monkeys
- Abstract # MO0410 - Semi-Mechanistic PK/PD Model of the Effect of Odanacatib, a Cathepsin K Inhibitor, on Bone Turnover to Characterize Lumbar Spine Bone Mineral Density in Two Phase II Studies of Postmenopausal Women
Osteoporosis model rats show improved healing with FGF-2 treatment