Zelos Therapeutics, Inc. has initiated patient dosing in a single dose study of three proprietary subcutaneous formulations of ZT-034 (hPTH (1-34), teriparatide). ZT-034 is being developed to compete with Eli Lilly and Company’s Forteo (teriparatide [rDNA origin]) in its existing market of approximately $800M in annual sales in 2008 for the treatment of osteoporosis. With the recent completion of safety studies demonstrating no damaging effects on the nasal lining, Zelos Therapeutics also plans to advance a novel, non-injectable nasal spray formulation of ZT-034 into clinical studies later this year. This simple and convenient dosage form could expand the market for parathyroid hormone (PTH) analogs such as teriparatide to considerably more than $1 billion.
“PTH analogs are particularly important in the management of osteoporosis patients who have a high risk of bone fractures because PTH stimulates the formation of new bone, in contrast to all other approved osteoporosis therapies,” stated Dr. Brian MacDonald, CEO of Zelos Therapeutics. “Teriparatide is underutilized in osteoporosis patients, primarily because of the high cost of treatment and the need for daily injections. Zelos Therapeutics’ proprietary injectable formulations of teriparatide may enable significant reductions in the cost of therapy, and our nasal spray formulation will offer a considerably more convenient method of daily dosing. We believe that our new formulations of teriparatide will make PTH therapy a viable option for many more patients and will enhance the ability of physicians to treat this debilitating disease.”
The 505(b)(2) regulatory pathway that Zelos Therapeutics will follow for the development of ZT-034 subcutaneous and intranasal formulations was added to the Federal Food, Drug and Cosmetic Act by the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This regulatory approach permits companies to obtain FDA approval of new drug applications (NDAs) by relying, in part, on the agency's findings of safety and/or efficacy for a previously approved drug. Section 505(b)(2) is intended to encourage innovation in drug development by permitting certain modifications of approved drugs without requiring duplicative studies to demonstrate what is already known about a previously-approved product.
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