Oral salmon calcitonin: Phase II data

The double-blind, U.S. Phase II TAR01-201 trial in 129 postmenopausal women with low bone mass at an increased risk of fracture showed that once-daily 200 mg oral Ostora met the primary endpoint of superiority to placebo in percent change from baseline in lumbar spine BMD at 1 year (p=0.026). Specifically, Ostora significantly improved lumbar spine BMD by 1.03% at 1 year compared to baseline (p<0.001), while placebo led to a 0.12% reduction in lumbar spine BMD from baseline to 1 year. Additionally, Ostora led to a significant placebo-adjusted reduction in levels of fasting CTX-I, a biomarker of bone resorption activity, of 20.2% from baseline to 1 year (p=0.034). The most common adverse events were respiratory infections and gastrointestinal.

Additionally, Tarsa reported pooled data from 678 postmenopausal women in TAR01-201 and the double-blind, international Phase III ORACAL trial showing that there was no carcinogenicity signal in patients receiving Ostora for 1 year. Data were presented at the American Society for Bone and Mineral Research meeting in Minneapolis. In 2011, Tarsa reported top-line data from ORACAL showing that Ostora met the primary endpoint by achieving superiority to placebo and non-inferiority to Miacalcin salmon calcitonin nasal spray in percent change from baseline in lumbar spine BMD at 1 year (see BioCentury, March 28, 2011). Novartis AG (NYSE:NVS; SIX:NOVN, Basel, Switzerland), which is supplying calcitonin to Tarsa, markets Miacalcin. ...