Zosano Pharma reports positive Phase II results from osteoporosis trial

Zosano Pharma, a specialty pharmaceutical company, has reported positive results from its Phase II study of the ZP-PTH rapid delivery patch for the treatment of osteoporosis.

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 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.

According to Zosano, 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%).

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, the company said.

Gail Schulze, CEO of Zosano, said: We continue to lay the groundwork for our Phase III program to further underscore the safety and efficacy of ZP-PTH. Our goal is to offer a new paradigm of treatment for millions of patients with a safe, effective and convenient therapy based on a proven bone forming agent.