Osteoporosis & Related Bone Disorders

The Wisconsin Alumni Research Foundation (WARF) is seeking commercial partners interested in developing novel compounds for the treatment of osteoporosis and related bone disorders.
 

Overview

Osteoporosis is a debilitating disease in which bones become fragile and more likely to break. According to the 2004 Surgeon General's report on bone health and osteoporosis, more than 1.5 million people in the United States suffer fractures as a result of osteoporosis each year. Osteoporosis causes 2.6 million visits to the doctor's office, 800,000 trips to the emergency room, 500,000 hospitalizations and 180,000 nursing home placements, and costs for treating fracture resulting from osteoporosis exceed $18 billion each year.

The normal process of bone remodeling involves carefully balanced rates of bone resorption and bone synthesis. Osteoporosis occurs when accelerated rates of bone resorption and declining rates of new bone synthesis alter the mineral content, density and structure of bone. This problem is particularly pronounced in post-menopausal women when declining levels of estrogen accelerate bone resorption rates while advancing age decreases the rate of bone synthesis. The decrease in bone mineral density is usually associated with an increased incidence of fracture, particularly in the weight bearing areas of the skeleton.

Hormone replacement therapy (HRT) was once the main treatment for osteoporosis in post-menopausal women because it effectively balanced bone resorption and new bone synthesis, critical processes essential for healthy bone remodeling. Bisphosphonate compounds have largely replaced HRT due to concerns that HRT may increase the risk of cancer. Bisphosphonates are designed to conserve bone mineral density and reduce fracture risk by slowing the rate of bone resorption; however, they do not stimulate new bone synthesis. Despite evidence of improved bone mineral density and a reduction in fracture rates, fractures continue to occur in treated patients. Therefore, a need exists for treatments that will improve the quality and strength of the bone that is preserved with anti-resorption treatments.

A Novel Treatment Approach: Anabolic analogs of calcitriol with high selectivity for bone and more favorable safety profiles.

UW–Madison researchers are investigating new treatments for osteoporosis that focus on improving bone quality and increasing bone strength by stimulating bone synthesis, in addition to blocking bone resorption. In recent years, analogs of the hormonally active form of vitamin D, known as calcitriol or 1,25 dihydroxyvitamin D3, have emerged as a promising focus for the development of anabolic osteoporosis therapies. Calcitriol has been shown to slow bone loss and reduce the risk of fractures, particularly when taken with calcium. However, bone synthesis has been only weakly observed at very high concentrations, and the concentration of calcitriol required to achieve observable levels of bone growth cannot be safely sustained due to excessive mobilization of intestinal calcium and the occurrence of dose limiting hypercalcemia.

Researchers at the University of Wisconsin are designing and studying promising new analogs of calcitriol that can stimulate new bone synthesis with little evidence of calcium mobilization in the intestine. These compounds could prove useful as bone strengthening agents for osteoporosis, either as monotherapy or in combination with anti-resorptive treatments.
 

Business Opportunity

  • Osteoporosis is a growing market and under-diagnosed disease in the United States. In 2009 it is estimated that 11 million people and 18% of the U.S. population over the age of 50 have osteoporosis. This number is expected to exceed 14 million by 2021.
  • The U.S. osteoporosis market generated revenues of $4.7 billion in 2008 and is expected to generate $6.5 billion by 2021.
  • Almost 90% of the treatments currently marketed for osteoporosis do not provide anabolic bone formation activity as their mechanism of action.
  • A clear need exists for new products that can improve current approaches to reducing fracture risks by forming new bone as well as preserve existing bone.
  • Extensive intellectual property rights may already be established in major market areas.
At the present time, a significant late-stage commercialization opportunity is available through our Licensee, Deltanoid Pharmaceuticals. For further information, please contact our office.
 

Applications

  • Osteoporosis
  • Osteopenia
  • Bone Repair

Key Benefits

  • Addresses the need for osteoporosis therapies with anabolic activity that may lead to greater bone strength and fracture resistance.
  • Offers a fresh approach for gaining access to the osteoporosis therapeutics market.
  • Provides an opportunity to leverage or expand existing therapeutic franchises through development of single agent treatments or combination product treatments with existing bone resorption inhibitor products.
  • Minimal development time required —early preclinical screening studies completed; late-stage/GLP preclinical and clinical evaluations may be available.
  • Innovative licensing and/or development terms are available.

Stage of Development

The analogs offered in this portfolio have been subjected to in vitro/in vivo models for evaluations of receptor binding, cell proliferation, cellular differentiation, calcium mobilization and blood calcium levels. In some cases, Good Laboratory Practice (GLP)-rated preclinical and clinical data may be available for evaluation.

Please contact our office for updates as study data sets may be evolving with compounds under development.
 

Additional Information

For more information about the inventor, see Hector DeLuca.
 

Contact Information

Please contact our licensing team at licensing@warf.org or 608.263.2500 to explore and discuss innovative development pathways that are available to qualified development interests.