BEDMINSTER, N.J.--(BUSINESS WIRE)--
NPS Pharmaceuticals, Inc. (NPSP), a biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases worldwide, yesterday presented findings supporting the therapeutic potential of Natpara (recombinant full-length human parathyroid hormone or rhPTH [1-84]) in poster sessions at ENDO 2013, The Endocrine Societys 95th Annual Meeting in San Francisco, CA. Natpara is a bioengineered replica of human parathyroid hormone that is being developed by NPS for adults with hypoparathyroidism, a rare and complex endocrine disorder that is characterized by insufficient levels of parathyroid hormone, the bodys principal regulator of calcium and phosphorus.
These findings suggest Natpara may provide an important new treatment option for patients with hypoparathyroidism by improving the calcium and phosphorus mineral imbalance associated with this complex disorder while significantly reducing the dependence on calcium and vitamin D supplementation, said Roger Garceau, MD, executive vice president and chief medical officer of NPS Pharmaceuticals. Our growing collection of clinical data for Natpara supports its therapeutic potential as the first replacement therapy targeting the underlying cause of adult hypoparathyroidism and we look forward to filing our U.S. Biologic License Application later this year.
Hypoparathyroidism is the only classic endocrine disorder without an FDA-approved replacement therapy. Current treatment approaches focus on symptom management through high doses of calcium and active vitamin D, which can lead to serious side effects and long-term consequences.
Treatment with Natpara resulted in maintained serum active vitamin D levels despite a significant reduction in active vitamin D requirements.
In a poster presentation on Sunday, June 16, lead study investigator Dolores M. Shoback, M.D., Professor in Residence at the University of California, San Francisco School of Medicine, presented results analyzing the effects of Natpara on vitamin D metabolism in patients with hypoparathyroidism in two clinical trials, a Phase 1 study and REPLACE, a Phase 3 registration study. The results indicate that Natpara treatment maintains serum levels of active vitamin D in the normal range despite a significant reduction in active vitamin D requirements, while maintaining serum calcium at or near baseline, and reducing 24-hour urinary calcium in patients deficient in endogenous PTH secretion.
All patients enrolled were prescribed calcium and active vitamin D supplements (calcitriol or 1 alpha calcifediol). In the Phase 1 study, patients received two doses of Natpara (50 and 100 g), separated by a washout period of seven days or more.
In the Phase 1 study, serum active vitamin D increased to maximum baseline-adjusted level of 27.2 18.3 and 19.6 11.0 pg/ml with the 50-g and 100g doses of Natpara, respectively. 24-hour urine calcium excretion decreased by 13% and 23% with the 50- and 100g doses, respectively. Serum calcium levels showed maximum mean increases of 0.7 to 0.9 mg/dL 12 hours after the Natpara injection and remained above baseline levels after 24 hours with either dose.
In REPLACE, 43% (36/84) patients treated with Natpara became independent of active vitamin D and reduced daily calcium to less than 500 mg/day versus 5% (2/37) patients in the placebo group by week 24 (P
At week 24, mean urine calcium decreased by -74 190 mg/24 hours in the Natpara group and -84 169 mg/24 hours in the placebo group (P=0.06). In the placebo arm, reductions in urine calcium were mirrored by decreased total serum calcium levels. In contrast, total serum calcium remained above or near the baseline levels in Natpara-treated patients. Serum calcium levels were significantly higher in the Natpara group versus the placebo group at weeks 1-16 (P
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