NPS Reports Positive Interim Data From Phase II Hypoparathyroidism Study
NPS Pharmaceuticals has reported positive interim data from an investigator-initiated Phase II proof-of-concept study of NPSP558, the proprietary recombinant full-length human parathyroid hormone for the treatment of hypoparathyroidism.
The interim data demonstrated that treatment with the proprietary recombinant full-length human parathyroid hormone (PTH 1-84) had a beneficial effect on abnormal bone skeletal properties in patients with hypoparathyroidism, a rare condition typified by insufficient or complete absence of parathyroid hormone and characterized by atypical structural and dynamic properties of bone.
The open-label Phase II study of PTH 1-84 for patients with chronic hypoparathyroidism is evaluating the effects of every-other-day subcutaneous injections of 100Ãƒ“šÃ‚µg of the drug on bone structure and turnover. This study is ongoing at Columbia University with John Bilezikian serving as the principal investigator.
The three studies being reported by the team are supported separately by the FDA’s Office of Orphan Products Development Grant Program and the National Institutes of Health.
NPS is currently preparing to initiate a pivotal registration study to demonstrate the safety and efficacy of NPSP558 for hypoparathyroidism, which it expects to begin in 2008.