The Phase I trial will investigate the comparative bioavailability of INP104 versus two approved DHE formulations.
Study to Explore Bioavailability and Safety of Novel, Intranasal Dihydroergotamine Delivered via Precision Olfactory Delivery Tec
| [31-October-2017] |
| SEATTLE, Oct. 31, 2017 /PRNewswire/ -- Impel NeuroPharma, a Seattle-based, privately-held biotechnology company focused on therapies for the treatment of central nervous system (CNS) disorders, today 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. About INP104 This Phase 1 study, INP104-101, is Impel’s first clinical study and is being conducted in Australia. The study will examine comparative bioavailability of three DHE arms, as well as explore safety and tolerability. Further details can be found on the ANZCTR website (www.anzctr.org.au) About Precision Olfactory Delivery™ or POD™ Technology About Impel NeuroPharma Impel NeuroPharma has is currently investigating INP104 (POD DHE) for acute migraine headache and INP103 (POD levodopa) for Parkinson’s Disease, as well as INP102 (POD insulin) for Alzheimer’s disease in an NIH funded trial. Impel NeuroPharma’s proprietary POD technology enables entirely new categories of drugs, including biologics, to be administered using a cost-effective, disposable, non-invasive intranasal drug delivery device. To learn more about Impel NeuroPharma, please visit our website at http://impelnp.com. Contact:
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