AEGIS ANNOUNCES RESULTS FOR INTRANASAL DELIVERY FORMULATION STUDY

Aegis Therapeutics has announced the completion of its first human clinical study -- a 10-patient, three-way crossover trial designed to confirm the effectiveness of Intravail absorption enhancement agents in increasing intranasal bioavailability of peptide and protein drugs. The study, using a currently marketed drug of approximately 4,000 Daltons in size, revealed an average systemic bioavailability of approximately 35 percent for the Intravail formulation compared with an average of 7 percent for the identical commercial formulation without Intravail. Intravail provides exceptionally high and unmatched bioavailability performance via the intranasal and other mucosal membrane administration routes.

Intravail allows the intranasal delivery of a growing number of peptide or protein drugs, such as insulin, growth hormone, parathyroid hormone, GLP-1, amylin, 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, Intravail intranasal formulations use standard and comparatively inexpensive homogeneous liquid formulation and fill technology and are administrable using simple off-the-shelf metered nasal spray devices.