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New Data From REPLACE Study Show Initiation Of Bone Remodeling For Natpara®-Treated Patients With Hypoparathyroidism

Stocks in this article: NPSP

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today new findings from the double-blind, placebo-controlled Phase 3 REPLACE study of Natpara ® (recombinant human parathyroid hormone (rhPTH [1-84]) that show Natpara initiated bone remodeling as demonstrated by significant increases in bone turnover markers. Investigators also reported results from an eight-week study, known as RELAY, which evaluated lower doses of Natpara in hypoparathyroidism. The findings were presented in a poster session at the Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Minneapolis, MN.

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, the body’s principal regulator of calcium and phosphorus. NPS expects to submit its Biologic License Application for Natpara by mid-2013.

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 on Monday, October 15, lead study investigator Dr. John P. Bilezikian and colleagues presented “Effect of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) on Skeletal Dynamics and BMD in Hypoparathyroidism: 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.

At baseline, a large percentage of Natpara-treated and placebo-treated patients in REPLACE had elevated bone mineral density (BMD) based on Z-scores and low bone turnover markers with no differences between the two groups. Rapid and statistically significant increases from baseline were observed at Week 24 in all bone turnover markers in the Natpara-treated group ( P<0.001 versus baseline for all markers) with no statistically significant changes observed in the placebo-treated group.

A summary of the average changes in bone turnover markers is summarized in the table below.

               
Natpara Placebo

Baseline(n=90)

       

Week 24(n=82)

 

Baseline(n=44)

 

       

Week 24(n=33)*

 

BSAP (µg/L) 9         30 9         10
CTX (ng/L) 233 1,032 237 260
P1NP (µg/L) 35 334 35 39
OC (µg/L) 4 30 4 4
 
* n=32 for BSAP at Week 24

BSAP: Bone-specific alkaline phosphatase

CTX: C-telopeptide

P1NP: N-terminal propeptide of type-1 collagen

OC: Osteocalcin

 

Investigators also reported statistically significant decreases in Z-scores towards normal from baseline to Week 24 in the hip for the Natpara-treated group versus placebo ( P<0.001).

Overall rates of adverse events during the 24-week treatment period were similar (90% vs. 96% Natpara and placebo, respectively). The spectrum of adverse events reflected underlying disease pathophysiology with most common being paresthesia, muscle spasms, headache, and hypocalcemia.

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