Impel NeuroPharma, a Seattle-based, privately-held biotechnology company focused on therapies for the treatment of CNS disorders, 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.
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.