08 Feb Impel NeuroPharma Announces Positive Results of Phase 1 Clinical Trial of INP104 for Treatment of Acute Migraine Headache
Novel, Intranasal Dihydroergotamine Dosed via Precision Olfactory Delivery, or POD™, Device Achieved Primary Outcome of Bioavailability, Safety
Study Marks First of Four Impel Clinical Trial Read Outs Planned for 2018
SEATTLE, Feb. 7, 2018 — Impel NeuroPharma, a Seattle-based, privately-held biotechnology company focused on therapies for the treatment of central nervous system (CNS) disorders, today announced positive results from a recently completed Phase 1 proof-of-concept trial of INP104 for acute migraine headache. INP104 is a novel dihydroergotamine (DHE) product dosed via Impel’s proprietary Precision Olfactory Delivery, or POD™, intranasal delivery device.
This proof-of-concept trial, INP104-101, demonstrated statistically significant improvement in bioavailability (Cmax and AUC) of INP104 over a currently approved dihydroergotamine mesylate nasal spray, and that bioavailability of INP104 was comparable to D.H.E. 45 (dihydroergotamine mesylate) intravenous (IV) injection after twenty minutes of exposure.
“DHE is a recognized gold standard treatment for acute migraine headache, however current delivery methods have created barriers to widespread use. This trial demonstrated that INP104 dosed via Impel’s POD™ device provided a consistent and desirable plasma pharmacokinetic profile,” commented Dr. John Hoekman, Impel’s founder and Chief Scientific Officer. “We are pleased with this outcome and we plan to commence a pivotal safety study in the United States in 2018.”
In addition to meeting the primary endpoint of bioavailability, INP104 was well tolerated. The majority of the clinical trial participants rated INP104 as a more acceptable method of delivery over the two comparators.
“In only a few months, Impel has generated compelling clinical data for INP104, and in 2018 we plan a rapid expansion in several clinical projects as we explore the use of the POD™ device in other CNS indications with unmet medical need,” said Jon Congleton, Chief Executive Officer of Impel. “The results of this trial support INP104 as a promising alternative for migraine patients and also validate the performance of the POD™ device to deliver medicine in a consistent and predictable manner via a novel intranasal route of administration.”
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. Further details of the INP104-101 study can be found on the ANZCTR website (www.anzctr.org.au) or ClinicalTrials.gov.
INP104 combines a currently approved formulation of dihydroergotamine (DHE) for intranasal delivery with Impel’s novel Precision Olfactory Delivery™, or POD™, device. The POD™ device is designed to propel a narrow plume of aerosolized DHE to the upper nasal space. The device is a simple-to-use, patient-friendly system that does not require coordination of inhalation with actuation of the device.
About Precision Olfactory Delivery™ or POD™ Devices
Impel NeuroPharma’s proprietary POD™ intranasal drug delivery device is designed to deliver drugs to the upper nasal cavity to achieve superior biodistribution and bioavailability of both small molecules and biologic drugs. By delivering therapeutics to the upper nasal cavity, the POD™ nasal delivery device may improve overall bioavailability of drugs and has the potential to target the brain via the olfactory and trigeminal nerves and to improve upon current treatment options for central nervous system (CNS) disorders. Impel has developed dry powder and liquid compatible POD™ devices.
About Impel NeuroPharma
Impel NeuroPharma, Inc., is a privately-held, Seattle-based company devoted to creating life-changing, innovative therapies for central nervous system (CNS) diseases. Impel’s products are based on a novel nasal drug delivery platform, the POD™ device, that administers drug to the upper nasal cavity in a consistent and predictable manner.
Impel NeuroPharma is currently investigating INP104 (POD™ DHE) for acute migraine headache, INP103 (POD™ levodopa) for Parkinson’s Disease, INP105 (POD™ olanzapine) for agitation in schizophrenia and bipolar disorders as well as INP102 (POD™ insulin) for Alzheimer’s disease in an NIH funded trial.
Impel NeuroPharma’s proprietary POD™ device enables small and large molecule drugs 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.
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