Impel NeuroPharma to Present Data from INP104 Clinical Program at the 61st Annual Scientific Meeting of the American Headache Society
posted in Press Releases by Marjorie Diddams
Previously Reported STOP 101 Data, Including New Analysis Evaluating Cardiovascular Effects of Dihydroergotamine Mesylate (DHE) Delivered by Impel’s POD® Device, Support Bioavailability, Safety and Tolerability Profile of INP104 for Acute Migraine
Company’s Phase 3 Clinical Program Evaluating INP104 for the Treatment of Acute Migraine Nearing Completion of Enrollment
SEATTLE, July 10, 2019 — Impel NeuroPharma, a late-stage biopharmaceutical company focused on the development and commercialization of transformative therapies for patients living with central nervous system (CNS) disorders with high unmet medical needs, today announced that it will present four scientific abstracts at the 61st Annual Scientific Meeting of the American Headache Society (AHS) held July 11-14 in Philadelphia, PA.
“We continue to be encouraged by the safety, tolerability and comparative bioavailability data emerging from our INP104 clinical program in acute migraine. The data we are presenting at AHS suggest that elevations in systolic and diastolic blood pressure associated with dihydroergotamine mesylate (DHE) therapy are linked to the peak drug concentration achieved during intravenous administration, which INP104’s upper nasal delivery route avoids,” said Jon Congleton, President and Chief Executive Officer of Impel. “Moreover, because DHE has historically demonstrated efficacy independent of where a person is in a migraine cycle, INP104 has the potential to be a differentiated acute treatment for this debilitating disease.”
The meeting abstracts are available online and can be accessed on the AHS meeting website at https://americanheadachesociety.org. All posters will be on display from Thursday, July 11 at 4:30 pm through Saturday, July 13 at 5:00 pm.
The following posters will have a Q&A session on Friday, July 12, 1:15 pm – 2:15 pm:
- STOP 301: Open-label Safety and Tolerability of Chronic Intermittent Usage for 24/52 Weeks of INP104 [Nasal Dihydroergotamine Mesylate (DHE) Administered by Precision Olfactory Delivery (POD®) Device] in Migraine Headache (Poster #44)
- Comparison of Early Plasma Exposure of DHE Following Nasal, Oral Inhalation, or Intravenous Administration (Poster #134)
- Dihydroergotamine, Then and Now (Poster #166)
The following poster will have a Q&A session on Saturday, July 13, 1:00 pm – 2:15 pm:
- Cardiovascular Profile of Dihydroergotamine Mesylate (DHE) Delivered by the POD® Device Compared to D.H.E. 45® for Injection from the STOP 101 Clinical Trial (Poster #31)
These data that will be presented at the meeting support the ongoing “STOP-301 Trial” (Safety and Tolerability of POD-DHE), a Phase 3, open-label safety and tolerability study evaluating long-term, intermittent use of INP104 for the treatment of acute migraine.
INP104 is a drug-device combination product being studied for the treatment of acute migraine. It is comprised of a nasal formulation of dihydroergotamine (DHE) and Impel’s proprietary Precision Olfactory Delivery, or POD®, device. The POD is a simple-to-use device designed to deliver consistent and predictable doses of drug. INP104, an investigational new drug, delivers DHE to the richly vascularized upper nasal cavity, offering the potential for rapid and consistent biodistribution without injection. DHE is an established and highly effective treatment option for acute migraine treatment.
About Acute Migraine
Migraine is a common and debilitating neurological disease characterized by recurrent episodes of severe head pain and associated with nausea, vomiting, sensitivity to light and to sound. Migraine affects approximately 39 million people in the United States. Of those diagnosed, only four million are on prescription treatment. While triptans account for almost 70 percent of migraine therapies, approximately 30 to 40 percent of patients do not respond adequately to triptan therapy and up to 79 percent of the treated patients report being dissatisfied with their current treatment and willing to try a new therapy.
IMPEL, POD and the IMPEL Logo are trademarks of Impel NeuroPharma, Inc. To learn more about Impel NeuroPharma, please visit our website at https://impelnp.com.
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