Impel NeuroPharma To Present Data From INP104 Clinical Program At The 19th Congress of the International Headache Society
posted in Press Releases by Marjorie Diddams
The Safety & Tolerability of INP104 is Currently Being Evaluated in the Company’s Recently Fully-Enrolled Pivotal Phase 3 “STOP-301” Trial
New Data from a Patient Experience Survey Describe Dissatisfaction Levels with Current Available Treatments & Desire for New Options That Offer More Rapid & Complete Relief of Migraine Symptoms with a Lower Side Effect Profile
SEATTLE, September 5, 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 19th Congress of the International Headache Society (IHC) being held September 5 – 8, 2019 in Dublin, Ireland.
“Our growing body of evidence supports the potential of INP104 to be a transformative new therapy for acute migraine. INP104 utilizes our sophisticated and proprietary new device technology to deliver optimal doses of dihydroergotamine (DHE) to the vascular-rich upper nasal cavity, resulting in peak drug concentration levels that may be more effective for patients,” said Stephen B. Shrewsbury, M.D., Chief Medical Officer of Impel NeuroPharma. “Importantly, because INP104 is designed to deliver a reduced dose of DHE compared to FDA-approved and investigational products in development, patients may be able to reap the established efficacy benefits of DHE, without the undesired side effects that are typically experienced with delivery to the lower nasal space.”
The meeting abstracts will be published in digital format within the official abstract book of the meeting which can be accessed on the IHC meeting website at http://www.ihc2019.com. Presented abstracts will also be published in Cephalalgia.
Four Impel-sponsored posters, including new findings from the I-BEAM patient experience and satisfaction survey, will be presented on Saturday, September 7 between 2:45-3:45 pm IST:
- 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 [IHC-PO-377]
- Comparison of Early Plasma Exposure to DHE by Nasal, Oral Inhalation, or Intravenous Administration [IHC-DP-036]
- A History of Dihydroergotamine in Migraine [IHC-PO-323]
- Impact and Burden of Episodic, Acute Migraine (I-BEAM): A Patient Experience Study [IHC-PO-299]
These data that will be presented at the meeting to support the ongoing “STOP-301 Trial” (Safety and Tolerability of POD-DHE), a Phase 3, open-label safety and tolerability trial evaluating long-term (24/52 week), 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 family of POD devices are 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 the approximately 19 million diagnosed migraine patients, 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 triptans and up to 79 percent of the treated patients report being dissatisfied with their current treatment and willing to try a new therapy.
About Impel NeuroPharma
Impel NeuroPharma, Inc., is a privately-held, Seattle-based biopharmaceutical company devoted to creating life-changing, innovative therapies for central nervous system (CNS) diseases. Impel NeuroPharma is currently investigating INP104 (POD-DHE) for acute migraine headache, INP103 (POD-levodopa) and INP107 (POD-carbidopa/levodopa) for reversal of OFF episodes in Parkinson’s disease and INP105 (POD-olanzapine) for acute agitation in schizophrenia and bipolar I disorder.
Impel’s product candidates are delivered via its proprietary Precision Olfactory Delivery, or POD®, technology which targets the richly vascularized upper nasal cavity with the goal of achieving enhanced bioavailability of therapeutic molecules.
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.
About Precision Olfactory Delivery or POD® Devices
Impel NeuroPharma’s proprietary POD® nasal drug delivery device is designed to deliver drugs to the richly-vascularized upper nasal cavity to improve biodistribution and bioavailability of both small molecules and biologic drugs. By consistently and predictably delivering therapeutics to the upper nasal cavity, the POD device may improve overall bioavailability of drugs without IV injection. Impel has developed dry powder and liquid compatible POD devices to improve upon current treatment options for central nervous system (CNS) disorders.
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