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news.Aegis Therapeutics has completed its first human clinical study designed to confirm the effectiveness of its Intravail absorption enhancement agents in increasing intranasal bioavailability of peptide and protein drugs.
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The 10-patient study, using a currently marketed drug of approximately 4,000 Daltons in size, revealed an average systemic bioavailability of approximately 35% for the Intravail formulation compared to an average of 7% for the identical commercial formulation without Intravail.
“These results quantitatively confirm the unmatched intranasal bioavailability reported previously in primate and non-primate animal studies,” said Don Grimm, Aegis’ executive chairman. “Intravail offers significantly greater bioavailability than recently published results using other current intranasal delivery technologies for similarly sized peptides.”
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, amylin, and interferon, among 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 simple “off the shelf” metered nasal spray devices.