Improvements in Disability and the Interictal Period with INP104: Results from the Phase 3 STOP 301 Study
posted in Presentations by Brooke Eger
Poster presented at the 15th Annual HCOP Winter Conference; Ojai, CA; January 28-29, 2022
Authors: Dawn C. Buse, PhD; Cynthia E. Armand, MD; Rob Vann, PhD; Sutapa Ray, PhD; Michelle Murphy, PhD; Stephen B. Shrewsbury, MB ChB; Sheena K. Aurora, MD
Purpose: INP104 is a drug-device combination product for the acute treatment of migraine that targets delivery of dihydroergotamine mesylate (DHE) to the upper nasal space using Precision Olfactory Delivery (POD®) technology. Reported here are data on headache-related disability using the Migraine Disability Assessment (MIDAS) questionnaire, evaluating time between migraine attacks and frequency of migraine attacks, which were exploratory outcome measures relevant to interictal burden, from the Phase 3, STOP 301 study of INP104 for the acute treatment of migraine.
Methods: STOP 301 study was a pivotal, interventional, open-label, Phase 3 study assessing the safety, tolerability, and exploratory efficacy of INP104 over 24 or 52 weeks. In total, 354 patients comprised the full safety set (FSS; i.e., all patients who enrolled and received ≥ 1 dose of INP104 1.45 mg) in the 24-week period and 73 patients in the 52-week period. Exploratory efficacy measures included the MIDAS questionnaire which was completed by patients during screening, baseline, at Weeks 12 and 24, and if applicable, at Weeks 36 and 52. The time between migraine attacks was also determined during screening and Weeks 1-24 of INP104 treatment using Kaplan-Meier methods to estimate the median interval length.
Results: For the 24-week FSS, the mean MIDAS total score for patients was 25.1 at baseline. The most frequent scores were Grade III (28.8%; 102/354) and Grade IVa (27.7%; 98/354), indicating moderate to severe disability at study initiation. For the 24-week FSS population, the mean MIDAS total score at Week 12 was 18.4, with a mean change from baseline of -5.5, and the mean 24-week FSS MIDAS total score was 17.4, with a mean change from baseline of -7.4. Most patients had improved MIDAS scores of Grade III or better at Weeks 12 and 24. For the 52-week FSS, the mean MIDAS total score for patients was 24.6 at baseline. The most frequent scores were Grade III (31.5%; 23/73) and Grade IVa (31.5%; 23/73), indicating moderate to severe disability at study initiation. At Weeks 12, 24, 36, and 52, the mean 52-week FSS MIDAS total score was 18.8, 20.3, 15.3, and 14.9, with a mean change from baseline of -5.8, -5.1, -7.8, and -8.9, respectively. Most patients had MIDAS scores of Grade III or better at Weeks 12, 24, 36, and 52. During Weeks 1-24, the median time between migraine attacks was 6 days compared to 4 days at baseline. The mean number of migraine attacks by 4-week intervals was 1303, 980, 785, 726, 676, and 638 at Weeks 4, 8, 12, 16, 20, and 24, respectively.
Conclusion: Use of INP104 was associated with improvements in migraine-related disability as assessed by the MIDAS questionnaire.