NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the randomization of the last patient in REPLACE, its Phase 3 registration study of NPSP558, a bioengineered form of human parathyroid hormone. REPLACE is a double-blind, placebo-controlled study evaluating the use of NPSP558 as hormone replacement therapy in adult patients with hypoparathyroidism. A total of 135 patients were randomized in this study.
“This is an important milestone in our NPSP558 pivotal study in hypoparathyroidism and we look forward to reporting top line results by the end of this year,” said Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals. “There are currently no approved treatments for hypoparathyroidism, a disease that can cause serious bone, muscular and neurological symptoms. Current treatment approaches are palliative and can lead to long-term health risks. As a replica of natural parathyroid hormone 1-84, NPSP558 has the potential to address this unmet need by treating the underlying cause of the disorder rather than just managing the symptoms.”
NPS believes positive results from REPLACE will enable it to file for U.S. marketing approval in 2012 for NPSP558 in hypoparathyroidism
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