Zosano Pharma, Inc. Closes Enrollment in Phase 2 Trial
FREMONT, Calif.--(BUSINESS WIRE)--Zosano Pharma, Inc. announced today that it has closed enrollment of its Phase 2 clinical trial evaluating a parathyroid hormone (hPTH 1-34) transdermal microprojection delivery system to treat post menopausal women with osteoporosis who are at a high risk of bone fracture. This enrollment was completed ahead of schedule. The results from the trial should be available in the second half of 2008.
“Closing enrollment early is an important milestone for Zosano,” said Cory Zwerling, Zosano’s Chief Executive Officer & President. “This achievement reflects positively on physician and patient acceptance of our PTH delivery system.”
Total worldwide osteoporosis drug sales are currently over $4B and are estimated to reach $10B by 2010. PTH is seen as the leading anabolic agent to help build bone mass in patients with severe osteoporosis. However, daily injections of PTH may not be convenient for many elderly osteoporotic women and may also lead to lower overall patient compliance.
“Zosano’s transdermal PTH delivery system offers patients needle-free convenience and a product that does not require refrigeration, which we believe will improve patient compliance and appropriately expand the PTH market. These differentiating features may be the contributing factors for our rapid enrollment in this trial,” said Mr. Zwerling. “In the future, this potential physician and patient acceptance may provide similar commercial benefits for all of Zosano’s product programs.”
Zosano's Macroflux® transdermal microprojection delivery system provides unique benefits, including convenient needle-free administration with room temperature stability for various therapeutic peptides, proteins, small molecules and vaccines. This transdermal system has been clinically tested in over 300 patients with four different peptides and a vaccine.
Zosano’s PTH delivery system is currently in Phase 2 clinical trials in the United States, Mexico and Argentina to select optimal dosing and is being compared to placebo and the marketed PTH product FORTEO® from Eli Lilly. The Phase 2 enrollment began in June 2007 and completed enrollment in mid-November 2007. The results of this trial will prepare the PTH delivery system for the Phase 3 trial. Thereafter, assuming continued positive clinical data, a 505(b)2 NDA submission is planned.
“The rapid enrollment in our Phase 2 program is a positive achievement for our company,” said Pete Daddona, PhD., Zosano’s Chief Scientific Officer. “In addition to this PTH milestone, we are exploring the development of our own proprietary product pipeline, as well as actively pursuing product partnership arrangements.”
“Zosano is focused on the successful implementation of our Phase 2 PTH program and the advancement of new product opportunities,” said Mr. Zwerling. “We believe our differentiating advantages of needle-free convenience and room temperature stability will become a sustainable platform to creating better pharmaceutical products with our innovative delivery.”
About Zosano Pharma, Inc.
Zosano Pharma, previously named The Macroflux Corporation, was founded in October 2006 as a Johnson and Johnson Internal Ventures spin-out from the ALZA Company to progress several product opportunities based on the company’s transdermal microprojection delivery system. Headquartered in new facilities in Fremont, California, Zosano Pharma currently has 44 employees. For further information, or to find out about licensing and partnering opportunities, visit www.zosanopharma.com.