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news.Zosano Pharma has announced positive results from its Phase II, randomized, multi-center, double-blind, multi-dose study designed to determine safety and efficacy of its ZP-PTH rapid delivery patch for the treatment of osteoporosis.
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The product delivers PTH 1-34, teriparatide (PTH), a compound that has been proven to stimulate formation of new bone and reduce the risk of fractures. The ZP-PTH patch uses a unique transdermal technology being developed as an alternative to daily injections, said Zosano.
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 40mcg patch, which effectively delivers 16mcg of PTH, was comparable to the Forteo 20mcg injection, in mean percent change from baseline in lumbar spine BMD (4.97% versus 3.55%), the company said. Treatment with ZP-PTH 40mcg 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. Gail Schulze, board chair and CEO of Zosano, said: "ZP-PTH combines PTH, an established bone forming agent, with Zosano's user-friendly transdermal patch technology to offer a promising therapeutic alternative for the treatment of osteoporosis. These strong results underscore our confidence in this product and we are preparing for our Phase III program in order to further demonstrate its safety and efficacy."