June 4, 2021 – Marco Meglio
Treatment with INP104 was associated with high rates of symptoms freedom and may be a promising new acute treatment for patients with migraine.
Timothy Smith, MD, RPh, FACP
Results from the phase 3 open-label STOP 301 study (NCT03557333) demonstrated that treatment with INP104 (Impel NeuroPharma) is associated with improvements in several migraine measures, with low recurrence rates, and is consistently effective throughout a 24-week stretch. The data was published across 3 abstracts which were presented at the 2021 Virtual American Headache Society (AHS) 63rd Annual Scientific Meeting, June 3-6.1-3
INP104, an investigational drug-device product that targets dihydroergotamine mesylate (DHE) to the upper nasal cavity using Precision Olfactory Delivery (POD) technology, had safety, tolerability, and exploratory efficacy assessed in STOP 301. The study comprised of a 4-week screening period, 24-week treatment period for all patients, a treatment extension to 52 weeks for a subset of the patients, and a 2-week post-treatment follow-up period.1
In the 24-week full safety set (FSS), the mean number of MAs self-reported as pain- and MBS-free 2-hours post-INP104 ranged from 35.1% to 38.7% and 49.2% to 57.9% compared to 30.6% and 47.9% at baseline, respectively. At 52 weeks, the mean number of MAs self-reported as pain- and MBS-free 2-hours post-INP104 ranged from 31.4% to 39% and 39.8% to 55.7% compared to 23.5% and 40.8% at baseline, respectively, in the 52-week FSS.
In total, 15% of MAs required a rescue medication over the 24-week stretch. Despite allowing a second INP104 dose within 24 hours, 90.9% of those opted to use non-INP104 medications in lieu of the second optional dose.
READ MORE: Rimegepant, Ubrogepant, Lasmiditan All Safe and Effective for Acute Migraine Treatment
INP104 also demonstrated a significant consistency of response. Over 24 weeks, 25%, 57%, and 59.9% of patients were 100%, 75% or greater, and 67% or greater responders, respectively. After 24 weeks, 22.2%, 58.3%, and 65.3% of patients were 100%, 75% or greater, and 67% or greater responders, respectively.
Treatment consistency was observed in a separate analysis that included 188 patients in the 24-week FSS who had 4 or more INP104-treated MAs in both weeks 1-12 and weeks 13-24. Within-person consistency in 2-hour headache response (2hHR) was defined as the proportion of treated MAs (100%, ≥75%, and ≥67%) having mild or no pain at 2-hours post-INP104.2
All told, the same or improved level of benefit with INP104 was observed in patients during weeks 13-24 vs weeks 1-12, indicating within-person consistency. Of those responding in 75 to less than 100% of MAs during weeks 1-12, the majority achieved the same or better level of response during weeks 13-24 (88.5%). Additionally, 65.2% of those who responded to 100% of MAs during weeks 1-12 remained at this threshold during weeks 13-24.
Results from a patient acceptability questionnaire (PAQ) and the Migraine Disability Assessment (MIDAS) were also examined based on consistency thresholds. As consistency of response increased, patient acceptability improved, and MIDAS scores declined.