Privately-held biotech Impel NeuroPharma touted positive results today from a Phase I trial of its acute migraine headache therapy.
The Seattle-based company’s drug is delivered intranasally using its Precision Olfactory Delivery device, which is designed to deliver drugs to the upper nasal cavity and target the brain using the olfactory and trigeminal nerves.
The proof-of-concept trial showed a statistically significant improvement in bioavailability compared to an approved nasal spray and that the bioavailability was comparable to an intravenous injection of the same drug, dihydroergotamine mesylate, after twenty minutes.
“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,” Impel’s founder & chief scientific officer, John Hoekman, said in prepared remarks. “We are pleased with this outcome and we plan to commence a pivotal safety study in the United States in 2018.”
The trial also showed that most participants preferred Impel’s intranasal delivery method compared to traditional dosing regimens.
“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,” CEO Jon Congleton added.
“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.”