According to Impel NeuroPharma, a Phase 1 proof-of-concept trial of its INP104 intranasal dihydroergotamine (DHE) for the treatment of acute migraine headache demonstrated comparable bioavailability for INP104 to IV DHE and a statistically significant increase in Cmax and AUC compared to Migranal DHE nasal spray. INP104 was also well tolerated, the company said.
INP104 is based on Impel’s precision olfactory delivery (POD) device technology. The company had announced initiation of the Phase 1 trial in October 2017.
Impel NeuroPharma Founder and Chief Scientific Officer John Hoekman said, “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. We are pleased with this outcome and we plan to commence a pivotal safety study in the United States in 2018.”
Impel CEO Jon Congleton added, “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. 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.”
Read the Impel NeuroPharma press release.