NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, yesterday presented findings from the company’s pivotal Phase 3 study of Natpara® (recombinant human parathyroid hormone 1-84, rhPTH(1-84)), known as REPLACE, suggesting the investigational therapy has a beneficial effect on bone health in patients with hypoparathyroidism. Investigators also reported findings from the PARADOX burden of illness survey suggesting that patients with hypoparathyroidism have a substantial burden of illness in the skeleton and joints and experience bone-related symptoms and comorbidities despite receiving standard care, such as calcium and active vitamin D. Findings from REPLACE and PARADOX were presented in respective poster sessions at the Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Baltimore, MD.
“The new findings presented from the REPLACE study add to the growing body of clinical evidence demonstrating the effects of Natpara in the treatment of hypoparathyroidism, a rare endocrine disorder,” said lead study investigator, John P. Bilezikian, MD, professor of medicine, Division of Endocrinology, Columbia University College of Physicians and Surgeons. “Treatment with Natpara may restore bone remodeling in patients with hypoparathyroidism, as shown by improvements in a number of measures. The data support the notion that Natpara may have a direct benefit on bone health.”
Natpara is a bioengineered replica of human parathyroid hormone that is being developed by NPS for adults with hypoparathyroidism, a rare endocrine disorder that is characterized by insufficient levels of parathyroid hormone, a principal regulator of the body’s mineral homeostasis. Abnormal bone structure with high bone mineral density is a well-recognized consequence of hypoparathyroidism that is likely caused by decreased bone turnover in the absence of parathyroid hormone.
In a poster session, lead study investigator Dr. John P. Bilezikian and colleagues presented “Changes in Bone Turnover Markers and Bone Mineral Density With Recombinant Human Parathyroid Hormone, rhPTH(1-84), in Hypoparathyroidism: Potential Utility as Surrogate Endpoints for Monitoring – the REPLACE Study.” The presentation focused on the effects of Natpara on changes in bone turnover markers and bone mineral density after 24 weeks of treatment in REPLACE.