Zosano's PTH Program

Zosano’s lead clinical program, the ZP-PTH rapid delivery patch for the treatment of osteoporosis is being developed as an alternative to daily injections. The product delivers PTH 1-34, teriparatide (PTH), a compound that stimulates formation of new bone and reduces the risk of fractures. 

The majority of products currently available for the treatment of osteoporosis are bisphosphonates, or anti-resorptive compounds which have been shown only to prevent future bone loss.  Anabolic compounds like PTH have been shown to stimulate formation of new bone and present a significant opportunity for market differentiation.  Currently, PTH is only available to patients via daily injection.

 Zosano is pursuing a 505b2 regulatory strategy that leverages existing PTH safety and efficacy data of the marketed product Forteo®.  Unlike Forteo® the ZP-PTH patch is needle-free patch that should be more user-friendly for patients. 

Zosano's PTH will be an important contributor to anabolic treatment or bone building options in the large global osteoporosis market, giving physicians a convenient and stable product for older women and men who currently are using daily injections. The anabolic ZP-PTH patch is differentiated from anti-resorbtives.

Clinical Pharmacokinetic Studies

In Clinical studies, the ZP-PTH patch demonstrates rapid drug absorption with a short patch wear time.

Phase 2 Study Demonstrated Increases in Bone Mineral Denisity

A Phase 2 study was performed in 15 centers in three countries and enrolled 165 postmenopausal women aged 50-81 who had been diagnosed with osteoporosis. 

Following 24 weeks of treatment ZP-PTH 40 mcg had more subjects achieve a percent change in BMD response greater than either 3% or 5%, while fewer subjects responded with less than a 2% increase in lumbar spine-BMD

The same study also demonstrated that ZP-PTH 40 mcg 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 (Figure 2). All ZP-PTH doses were well tolerated with no systemic adverse events different from Forteo^® and there were no clinically significant sustained occurrences of hypercalcemia in any treatment group.

A dose ranging effect was seen with ZP PTH on total hip BMD that has not been previously obseerved with Forteo^®

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. According to the National Osteoporosis Foundation, 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.