Data Will Evaluate Exploratory Efficacy Data from STOP-301 Study Evaluating INP104 Consistency of Response, Recurrence and Sustained Response
Findings Also Highlight Safety and Tolerability Including Nausea and Nasal and Cardiovascular Safety as a Promising Potential New Option for the Treatment of Acute Migraine Attacks
Investigational INP104 is dihydroergotamine mesylate (DHE) delivered directly into the vascular-rich upper nasal space using Impel’s proprietary Precision Olfactory Delivery (POD®) technology. Many current nasal delivery technologies – sprays, droppers, and pumps – may deliver less than 5% of the active drug to the upper nasal space.1
“We are proud to share data that further strengthens the INP104 safety, tolerability and exploratory efficacy profile and builds upon evidence that it may be a promising new acute treatment for migraine attacks, offering consistent and sustained relief,” said
Impel will share data from its pivotal Phase 3, open-label “STOP-301” study evaluating INP104 for the acute treatment of migraine, including patient-reported exploratory efficacy findings for pain and most bothersome symptom relief and freedom regarding consistency and sustainability of response and migraine recurrence. STOP-301 safety and tolerability data presentations will include findings on nausea, as well as nasal and cardiovascular safety. STOP-301 is a Phase 3, pivotal, open-label trial evaluating the safety, tolerability, and exploratory efficacy of INP104. Additionally, Impel will present a literature review regarding DHE pharmacology and DHE’s broad receptor profile.
“A high percentage of people with migraine experience nausea, vomiting and other gastrointestinal symptoms. Among these people, there is variability in absorption of oral medications,” said
STOP-301 data presented at AHS includes:
- A post-hoc analysis found that INP104 treatment showed high levels of consistency across multiple migraine attacks over 24 weeks.
- Presentation Title: Treatment Consistency Across Multiple Migraine Attacks: Results from the Phase 3 STOP 301 Open-Label Study
- Abstract Number: 1001404
- A single dose of INP104 was associated with high rates of sustained efficacy for those who had obtained relief with INP104 for their first treated migraine. In addition, the data found that treatment with INP104 was associated with low rates of migraine recurrence.
- Presentation Title: Recurrence Rates for INP104 for the Acute Treatment of Migraine: Results from the Phase 3 STOP 301 Open-Label Study
- Abstract Number: 1001469
- Of the 6,332 doses of INP104 administered, less than 1% of doses were reported to result in nausea. The majority of reported instances of nausea were mild to moderate in severity.
- Presentation Title: Reduced Nausea When Dihydroergotamine Mesylate Is Delivered by INP104
- Abstract Number: 1001405
- In the absence of a direct comparison, results suggest that INP104 was associated with high rates of symptom freedom and may be a promising new acute treatment for migraine.
- Presentation Title: Acute Treatment of Migraine with INP104: Exploratory Efficacy from the STOP 301 Phase 3 Study
- Abstract Number: 1001475
- No significant adverse events were noted in the peripheral or cardiovascular (CV) system, even in patients with CV risk factors or concomitant triptan use.
- Presentation Title: Cardiovascular Safety Results of INP104 (POD-DHE) from the STOP 301 Phase 3 Study
- Abstract Number: 1001476
- Over 90% of patients had normal upper nasal endoscopies reported throughout the 24-week trial. Mild to moderate edema was observed in the nasal mucosal, but was not considered a concerning finding.
- Presentation Title: Nasal Safety of Chronic Intermittent Use of INP104: Results from the Phase 3 STOP 301 Open-Label Study
- Abstract Number: 1001356
In addition to STOP-301 data, Impel will also present:
- A literature review of new and existing migraine-specific treatments, which found that compared to other therapies, DHE displays a broad range of pharmacological activity across multiple receptors, including serotonergic (5-HT), adrenergic (), and dopaminergic (D) receptor subtypes, therefore exerting a greater influence over the pathophysiology of the migraine cycle.
- Presentation Title: DHE Pharmacology revisited: Does a broad receptor profile molecule treat the whole migraine?
- Abstract Number: 1001481
- A study comparing clinical outcomes of INP104 versus gepants and DHE nasal spray by an industry standard matching-adjusted indirect comparison (MAIC). The study found INP104 was associated with greater reductions in pain and other migraine-related symptoms in indirect comparison with gepants.
- Presentation Title: Assessing the Comparative Efficacy of INP104 For Acute Treatment Of Migraine Attacks: A Matching-Adjusted Indirect Comparison
The New Drug Application (NDA) for INP104 was accepted for review by the
All presentations will be accessible on the AHS website at https://www.americanheadachesociety.org/. Presentation details are highlighted below.
About STOP-301:
STOP-301 was a pivotal, Phase 3 open-label study that evaluated the safety, tolerability, and exploratory efficacy of INP104. The trial enrolled 360 patients at 36 sites in
In the trial, 354 patients received at least one dose of INP104 and comprised the 24-week Full Safety Set. Of the 185 patients who took an average of two or more treatments with INP104 per 28-day period during the 24-week treatment period comprised the Primary Safety Set. Of those enrolled, 74% (n=262) of patients completed the 24-week treatment period. A subset of 73 patients continued into a 28- week treatment extension period to 52 weeks total, of which 90% completed.
About Precision Olfactory Delivery or POD® Technology:
Impel’s proprietary Precision Olfactory Delivery (POD®) technology is able to deliver a range of therapeutic molecules and formulations into the vascular-rich upper nasal space, believed to be a gateway for unlocking the previously unrealized full potential of these molecules. By delivering predictable doses of drug directly to the upper nasal space, Impel’s precision performance technology has the goal of enabling increased and consistent absorption of drug, overriding the high variability associated with other nasal delivery systems, yet without the need for an injection. While an ideal target for drug administration, to date no technology has been able to consistently deliver drugs to the upper nasal space. By utilizing this route of administration,
About Migraine and About the Acute Treatment of Migraine:
Migraine is a common and debilitating neurological disease characterized by recurrent episodes of severe head pain and associated with nausea, vomiting and sensitivity to light and sound.2 Migraine affects approximately 36 million people in
About
Cautionary Note on Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the
Contact:
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1. Silberstein SD, et al. Headache. 2020;60:p 47/col 2/para 1.
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7. Bigal M, Rapoport A, et al. Satisfaction with current migraine therapy: experience from 3 centers in US and
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