Impel NeuroPharma has dosed the first patient in the Phase lll Safety and Tolerability of POD-DHE (STOP-301) trial to investigate the safety and tolerability of INP104 for the treatment of acute migraine headache.
The open-label, single-group assignment trial is expected to enrol 200 subjects.
The trial is designed to study the long-term, intermittent use of INP104 for 24 or 52 week period, during which INP104 will be administered intranasally using Impel’s I123 precision olfactory delivery (POD) device.
It will also gather efficacy data of INP104 as analysed by change from baseline in migraine measures during the course of the study.
Primary objects of the trial are serious treatment emergent adverse events (SAEs) and non-serious treatment emergent adverse events (AEs), for up to 54 weeks.
They also include change in nasal mucosa and change in olfactory function, for baseline of up to 52 weeks.
After a complete review of the trial data, Impel NeuroPharma is expected to file a new drug application (NDA) for INP104 in the second half of next year.
Impel NeuroPharma CEO Jon Congleton said: “We believe that INP104 stands to provide a gold-standard migraine therapy in a device that offers rapid and optimised bioavailability.”
INP104 is a new dihydroergotamine (DHE) drug-device combination product currently under development for acute migraine headache, a common neurological disease characterised by recurrent episodes of severe head pain and associated with nausea, vomiting, sensitivity to light and to sound.
Migraine is estimated to affect more than 36 million people in the US and more than 90% of these patients have acute migraines with an average of less than four migraine days per month.