Zelos Therapeutics and Aegis Therapeutics Announce Collaboration for Intranasal Delivery of Zelos’ ZT-031

Zelos Therapeutics, Inc. (West Conshohocken, PA) and Aegis Therapeutics LLC (San Diego, CA) have announced a collaboration for the development of an intranasal spray formulation of the proprietary parathyroid hormone (PTH) analog ZT-031 [Ostabolin-C, cyclic PTH-(1-31)]. Under the collaboration, which is exclusive across the PTH field, Zelos will utilize Aegis’ patented Intravail permeation enhancer technology to develop an intranasal version of ZT-031 for the treatment of osteoporosis and other bone diseases. A subcutaneous formulation of ZT-031 has already successfully completed a 12-month Phase 2 clinical trial in the treatment of osteoporosis.

Intravail allows the intranasal delivery of a growing number of peptide or protein drugs used to treat a wide range of human diseases. Examples include insulin, growth hormone, parathyroid hormone, GLP-1, and interferon, among many others. Unlike dry powder inhalable systems for pulmonary delivery of peptide drugs to the lungs that require specialized and expensive controlled-particle-size manufacturing technology, Aegis’ Intravail intranasal formulations use standard and comparatively inexpensive homogeneous liquid formulation and fill technology, and are administrable using off-the-shelf metered nasal spray devices that avoids the possibility of lung exposure.

ZT-031 [Ostabolin-C, cyclic PTH-(1-31)] is a proprietary cyclic 31-amino acid parathyroid hormone (PTH) analog. In a 12-month Phase 2 study in postmenopausal women with low bone mass, a subcutaneous formulation of ZT-031 was demonstrated to be a powerful bone formation agent with a rapid onset of effect, leading to clinically important increases in bone mineral density (BMD) at doses with low potential for calcium related toxicity. ZT-031 is expected to enter Phase 3 trials in osteoporosis this year, and clinical programs in fracture repair and renal bone disease indications are planned to begin over the next year.