Nastech Pharmaceutical Company Inc, of Bothell, Washington, a leader in molecular biology-based drug delivery technologies, has announced that data from its phase I study of intranasal parathyroid hormone (PTH 1-34) met bioavailability and safety goals. The trial data confirmed that this drug administration route produced a pharmacokinetic (PK) profile similar to that obtained by the approved subcutaneous product, teriparatide (Forteo^® ; Eli Lilly and Co). 

The trial was conducted in 12 healthy subjects between the ages of 20 and 40 who received one 20 µg subcutaneous injection of teriparatide followed by successive doses of the investigational PTH 1-34 nasal spray to allow for PK comparison in the same subject. The study achieved its goal of demonstrating similar PK profiles and showed that the intranasal PTH 1-34 formulation was well tolerated.

Nastech is planning a 6-month noninferiority trial with a bone mineral density (BMD) endpoint in 2006, and has already initiated a follow-on phase I PK study in the elderly as part of its clinical development program.

PTH 1-34 is a peptide fragment of the naturally occurring human PTH that is an important regulator of calcium and phosphorous metabolism. When administered as a daily subcutaneous injection, PTH 1-34 has been shown to increase BMD and reduce the risk for fractures in postmenopausal women. Daily injections of PTH 1-34 are approved for the treatment of postmenopausal osteoporosis.

—A. Techman