Nastech initiates trial of nasal osteoporosis treatment

The study will be conducted using the company’s advanced intranasal formulation that utilizes its ‘Tight Junction’ drug delivery technology to enable needle-free delivery of therapeutic levels of drugs, such as peptides and proteins, which would otherwise require an injection.

The objective of the study will be to determine the nasal absorption and safety of Nastech’s parathyroid hormone PTH1-34 nasal spray in comparison to an approved subcutaneous product. The study is the first of several designed to help select the commercial formulation and determine the appropriate dose to be used in the future clinical studies required for approval.

The pivotal clinical trial, on which an FDA submission will be based, will be a 6-month non-inferiority study comparing PTH1-34 nasal spray with the approved subcutaneous product measuring bone mineral density levels as the endpoint.

Dr Steven Quay, chairman, president and CEO of Nastech said: “The intranasal PTH1-34 clinical program provides Nastech with the opportunity to rapidly develop and commercialize an intranasal formulation of a product that has been shown to be safe and effective in the treatment osteoporosis but whose use and market potential may have been significantly constrained by the requirement for daily injections.”

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.