Apr 6 2009
Zosano Pharma, Inc., a privately held pharmaceutical company developing products using a novel transdermal delivery technology, 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.
Dr. Felicia Cosman, medical director of the clinical research center at Helen Hayes Hospital in West Haverstraw, New York, presented the study in a poster session on behalf of the study's participating investigators.
"By combining PTH, an established bone forming agent, with Zosano's rapid delivery, user-friendly patch technology, we have the potential to offer patients an alternative to daily injections in a safe, effective and convenient treatment for osteoporosis," commented Dr. Cosman. "We are encouraged that ZP-PTH produced gains not only in lumbar spine bone mineral density but also to a greater degree in total hip BMD relative to Forteo . We believe that this product offers great promise for patients."
"We continue to lay the groundwork for our phase 3 program to further underscore the safety and efficacy of ZP-PTH," stated Gail Schulze, Zosano's board chair and CEO. "The National Osteoporosis Foundation estimates that 44 million Americans - or approximately 55 percent of people 50 years or older - have osteoporosis. 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."
Study Design
The study was performed in 15 centers in three countries (United States, Argentina and Mexico) and enrolled 165 postmenopausal women aged 50-81 (mean age of 64 years) who had been diagnosed with osteoporosis.
Subjects were randomized to one of five treatment groups: ZP-PTH 20 mcg, 30 mcg, 40 mcg, or ZP placebo patch or Forteo 20 mcg injection. All study participants were taught self-administration techniques and thereafter self-administered their medication. The ZP-PTH or placebo patch was applied to the lateral abdomen, alternating left and right sides on a daily basis and worn for 30 minutes, and the Forteo 20 mcg/daily injection was administered in the abdomen or thigh.
Study participants were assessed monthly for six months after randomization. BMD measurements of common osteoporosis sites were performed at baseline and at six months. An additional BMD measurement of the lumbar spine was performed at a three-month visit.
The primary efficacy variable was the mean percent change from baseline in lumbar spine BMD at week 24 of dosing for active ZP-PTH patch treatment groups compared to ZP placebo patch.
About Osteoporosis
Osteoporosis is a disease characterized by low bone mass and the deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures. While any bone can be affected, fractures of the hip, spine and wrist are especially common. Osteoporosis is a major public health issue, affecting 55% of people 50 years or older in the U.S. Approximately 80% of those affected are women. By 2025, experts predict that osteoporosis-related fractures will be responsible for an estimated $25.3 billion in medical costs , an economic burden comparable to other major chronic diseases.
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