Impel NeuroPharma announced that the first patient was dosed in the recently-initiated Phase 1 clinical trial of INP104 for acute migraine headache. INP104 is a novel dihydroergotamine (DHE) product delivered via Impel’s proprietary Precision Olfactory Delivery, or POD™, intranasal delivery platform.
This trial will investigate the comparative bioavailability of INP104 versus two approved DHE formulations – D.H.E. 45 (dihydroergotamine mesylate) intravenous (IV) injection (100% bioavailability), and Migranal® (dihydroergotamine mesylate, USP) Nasal Spray (reported ~32% bioavailability).
DHE is a drug often used in specialist headache clinics for acute migraines, but current methods of administration by injection or traditional nasal spray devices create barriers to their widespread use.
“We believe the consistent, reliable, dose-to-dose delivery of product via Impel’s POD intranasal device holds the promise to improve systemic levels of DHE that were previously unachievable without injection,” said Jon Congleton, chief executive officer of Impel NeuroPharma. “Migraine affects more than 36 million people in the United States, and over a third of these have breakthrough acute migraines that are poorly addressed with currently-available treatments.”
“This Phase 1 bioequivalence trial will provide initial safety and tolerability data for INP104, and if predetermined, comparative bioavailability is proven, these data will serve as the basis for enabling a pivotal safety study of INP104 in 2018, with the intent to file a new drug application (NDA) in 2019,” commented John Hoekman, chief scientific officer and founder of Impel NeuroPharma.