Nastech initiates intranasal clinical development
Nastech Pharmaceutical has commenced a Phase I clinical trial to evaluate intranasal administration of human parathyroid hormone 1-34 (PTH1-34) in healthy subjects.
Nastech Pharmaceutical has commenced a Phase I clinical trial to evaluate intranasal administration of human parathyroid hormone 1-34 (PTH1-34) in healthy subjects.
The objective of the Phase I study is to determine nasal absorption and safety of Nastech's investigational PTH1-34 nasal spray formulation versus the approved subcutaneous injection.
'We are pleased to have added PTH1-34 to a list of nasal dosage forms of large-molecule peptides and proteins that Nastech has tested in humans,' stated Dr Steven Quay, chairman, president, and ceo. 'PTH1-34 Nasal Spray, for which we have filed patent applications, represents an important opportunity to expand our portfolio of intranasal dosage forms based on our proprietary Tight Junction drug delivery technology. The potential global market for a nasal spray dosage form of PTH1-34 is significant.'
About PTH1-34 and Osteoporosis
PTH1-34 is a fragment of the naturally occurring human parathyroid hormone that is an important regulator of calcium and phosphorus metabolism. When given by daily injection, PTH1-34 has been shown to increase bone mineral density and significantly reduce fractures in postmenopausal women. For example, subcutaneous PTH1-34 given with calcium and vitamin D reduced the risk of fractures by 65% compared with calcium and vitamin D alone. With respect to bone mineral density (BMD), daily subcutaneous PTH1-34 produced a 12% increase in lumbar spine BMD after 18 months of treatment. Daily injections of PTH1-34 are approved for the treatment of postmenopausal osteoporosis. Osteoporosis is a major public health issue. According to the National Osteoporosis Foundation, the estimated US patient population is 10m, with an estimated annual national health expenditure of more than $17bn.