Impel NeuroPharma 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," said 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.
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.
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.