Zosano Pharma Presents Positive Phase 2 Results of Its Needle-Free Osteoporosis Therapy
News Apr 06, 2009
Zosano Pharma, Inc. has presented positive results from its phase 2 study of the ZP-PTH rapid delivery patch for the treatment of osteoporosis at the 8th International Symposium on Osteoporosis in Washington, D.C.
The study was a randomized, multi-center, double-blind, multi-dose trial designed to determine safety and efficacy of the ZP-PTH rapid delivery patch for the treatment of osteoporosis. Using Zosano’s unique transdermal technology being developed as an alternative to daily injections, ZP-PTH delivers PTH 1-34, teriparatide (PTH), a compound proven to stimulate formation of new bone and reduce the risk of fractures.
The primary objective of the study was to assess safety and evaluate the effect of three doses of ZP-PTH on lumbar spine bone mineral density (BMD) after 24 weeks relative to placebo in postmenopausal women with osteoporosis.
Secondary study objectives were to evaluate the effect of three doses of ZP-PTH on total hip, femoral neck and forearm BMD relative to placebo and injectable Forteo®. The study enrolled 165 patients between 50 and 81 years of age with severe osteoporosis and was conducted at multiple sites across North and South America.
The study results demonstrated that daily administration of all three doses of ZP-PTH for 24 weeks resulted in a significant gain in BMD of the lumbar spine over placebo (p<0.001). The ZP-PTH 40 mcg patch, which effectively delivers 16 mcg of PTH, was comparable to the Forteo® 20 mcg injection, in mean percent change from baseline in lumbar spine BMD (4.97% versus 3.55%).
Treatment with ZP-PTH 40 mcg also showed a significant increase in total hip mean percent change from baseline in BMD (+1.33%) compared to placebo (-0.634%) and Forteo® (0.094%), both at p<0.05. All ZP-PTH doses were well tolerated with no systemic adverse events different from Forteo®. There were no clinically significant sustained occurrences of hypercalcemia in any treatment group.