Novel Drug Candidates for Secondary Hyperparathyroidism (SHPT), Renal Osteodystrophy and Diabetic Nephropathy

The Wisconsin Alumni Research Foundation (WARF) is seeking commercial partners interested in developing novel compounds for the treatment of chronic kidney disease (CKD).
 

Overview

Many patients with diabetes, particularly those with uncontrolled blood sugars, develop kidney damage. This damage, known as diabetic nephropathy, is a major cause of death in individuals with diabetes. It also is the leading cause of CKD in the United States.

Renal osteodystrophy is a debilitating bone disease found in patients suffering from CKD. It occurs when the kidney loses its ability to maintain the proper balance of calcium and phosphorous in the blood. A healthy kidney filters toxins and excess nutrients from the blood. It also stimulates intestinal absorption of calcium and phosphate by synthesizing calcitriol, the active form of vitamin D.

But in patients with CKD, calcitriol cannot be synthesized, resulting in hypocalcemia. In addition, nutrients, particularly phosphorous, accumulate in the blood. Hypocalcemia and excess phosphorous stimulate the secretion of parathyroid hormone (PTH), which causes the resorption of calcium and phosphorous from bone. Left untreated, hyperplasia of the parathyroid glands can occur. Prolonged exposure to elevated levels of PTH can lead to excessive demineralization of bone and weakening of the skeleton.

To suppress PTH, synthetic forms of calcitriol are used to restore blood calcium to acceptable levels. However, these compounds stimulate calcium and phosphorous absorption in the intestine, potentially causing dose-limiting hypercalcemia and hyperphosphatemia.

New Treatments: Improved non-calcemic analogs of calcitriol
 
Currently approved products for use in renal osteodystrophy, SHPT and diabetic nephropathy were discovered by researchers at the University of Wisconsin (Calcijex©, Rocaltrol©, Hectorol© and Zemplar©), and research continues to identify analogs that can more effectively suppress PTH and further reduce dose-limiting hypercalcemia and hyperphosphatemia. New compounds that have been discovered are showing great promise for further advancing the efficacy and safety of SHPT treatments. Early stage in vivo data suggests these new compounds provide wide therapeutic indexes, making them excellent development candidates for SHPT treatments.

In addition, the new vitamin D compounds may be able to maintain kidney function in patients with early stage CKD. When given in combination with other therapeutics, they also show potential for preventing the development of nephropathy in patients with diabetes.
 

Business Opportunity

  • The market for vitamin D analogs used to treat SHPT and renal osteodystrophy in the U.S. was estimated to be worth more than $800 million at the end of 2008.
  • The U.S. Renal Data Service (USRDS) estimated approximately 330,000 people received dialysis treatment for stage 5 CKD in 2006 and that the U.S. CKD population is expected to increase 60% by 2020.
  • In 1997, treatment of diabetic patients with stage 5 CKD in the U.S. cost more than $15.6 billion.
  • Improving treatment outcomes relating to bone and mineral disorders is a central theme in CKD patient management strategies.

Applications

  • Oral and intravenous treatments for management of SHPT and renal osteodystrophy in CKD patients.
  • Prevention or treatment of diabetic nephropathy.
  • Maintenance of kidney function in patients with early stage CKD.

Key Benefits

  • Proven biologically active compounds selected to target and suppress PTH levels.
  • Provides safer, less calcemic and less phosphatemic compounds than the natural hormone calcitriol or currently marketed treatments.
  • Offers a fresh therapeutic approach for gaining access to the kidney disease market.
  • Provides a drug development opportunity in a growing market space.
  • Strong intellectual property rights and development incentives are available.

Stage of Development

Many of the analogs offered in this portfolio have been subjected to in vitro/in vivo models for evaluations of receptor binding, cell proliferation, cellular differentiation, bone and intestinal calcium mobilization. In some cases, Good Laboratory Practice (GLP)-rated preclinical and clinical data may also 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.