Zelos Therapeutics commences dosing in clinical study of ZT-034 nasal spray for osteoporosis

Zelos Therapeutics, Inc. has initiated dosing in a seven day clinical study of a nasal spray formulation of ZT-034 (teriparatide) that is being developed in collaboration with development partner Aegis Therapeutics, LLC. Nasal spray ZT-034 is being developed as an alternative to Eli Lilly and Company’s Forteo (teriparatide [rDNA origin]) which generated approximately $800M in annual sales in 2009 for the treatment of osteoporosis and is administered by daily injection. Non-injectable formulations such as nasal spray ZT-034 could expand the market for parathyroid hormone (PTH) analogs to considerably more than $1 billion. The study design will include a Forteo treatment arm to provide an initial comparison with the marketed product.

“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.”

“PTH analogs such as teriparatide are an important but underutilized therapeutic option for osteoporotic patients at high risk of fracture,” stated Dr. Brian MacDonald, CEO of Zelos Therapeutics. “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.”

Nasal spray ZT-034 is formulated with Aegis Therapeutics’ proprietary agent Intravail® to create a stable solution of teriparatide and enhance absorption of the peptide across the nasal mucosal surface. “We are pleased to be working with Zelos on this important application of our drug delivery technology,” commented Dr. Ed Maggio, CEO of Aegis Therapeutics. “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.”

Zelos Therapeutics 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). 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.