The company said that the Nasal spray ZT-034 is being developed as an alternative to Eli Lilly’s Forteo (teriparatide [rDNA origin]), for the treatment of osteoporosis, and is administered by daily injection. The study design is expected to include a Forteo treatment arm to provide an initial comparison with the marketed product.
Nasal spray ZT-034 is formulated with Aegis’ proprietary agent, Intravail, to create a stable solution of teriparatide and enhance absorption of the peptide across the nasal mucosal surface.
Reportedly, Zelos plans to develop nasal spray ZT-034 under the 505(b)(2) regulatory pathway, that was included in the Federal Food, Drug and Cosmetic Act by the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments).
Furthermore, the 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.
Ed Maggio, CEO of Aegis, said: “We are pleased to be working with Zelos on this important application of our drug delivery technology. Intravail has produced dramatic increases in intranasal bioavailability for many peptides and other difficult to deliver therapeutics, in a simple, well tolerated method of delivering peptides without an injection.”
Brian MacDonald, CEO of Zelos, said: “PTH analogs such as teriparatide are an important but underutilised therapeutic option for osteoporotic patients at high risk of fracture. We believe that formulation of teriparatide as a nasal spray with comparable efficacy and safety to Forteo represents a simple, convenient approach to dosing that will make PTH therapy a better option for many more patients.”