Impel NeuroPharma Presents Data From Pivotal Phase 3 Registration Study Of INP104 For The Treatment Of Acute Migraine At 2020 Migraine Trust Virtual Symposium
SEATTLE, Oct. 8, 2020 /PRNewswire/ -- 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 has presented patient-reported outcomes data from the Company's pivotal Phase 3, open-label study "STOP 301" of INP104 (dihydroergotamine mesylate) or DHE using the company's proprietary POD technology, for the treatment of acute migraine in an oral presentation at the Migraine Trust Virtual Symposium (MTIS) to be held from October 3-9, 2020.
"Despite several recent approvals, there remains a significant need for acute treatments that provide early and sustained relief, are easy to use and well tolerated," said Stephen Shrewsbury, M.D., Chief Medical Officer at Impel NeuroPharma. "The response between the safety and efficacy results from STOP-301 combined with the patient-reported tolerability, acceptability and exploratory efficacy results are encouraging and provide further evidence that INP104, the first and only product designed to deliver DHE to the vascular-rich upper nasal space using our proprietary POD technology, may offer a promising treatment option for the acute treatment of migraine."
In the trial, 360 adult patients with migraine were enrolled in a 28-day screening period, during which they received "best usual care." Over a period of 24 weeks, patients were permitted to self-administer up to three doses of INP104 nasally per week (1.45 mg). Among participants, there were 4,515 reported migraines. Within two hours of receiving their first dose of INP104, 38% of all patients reported freedom from migraine pain, 52% had freedom from their most bothersome migraine symptom (MBS) and 66.3% experienced pain relief. About 84% of patients reported INP104 easy to use and preferred it over their current therapy.
Additionally, sustained pain freedom through 24 hours was also reported in the majority of patients with 98.4% of patients remaining relapse-free of their migraine after using INP104 for 24 weeks. The most common treatment-emergent adverse events (TEAEs) were nasal congestion (15.0%), nausea (6.8%), nasal discomfort and unpleasant taste (5.1% each) with all other TEAEs being reported by less than 3% of participants. There were no treatment related Serious AEs, cardiac TEAEs or deaths.
The oral presentation and additional INP104 posters accompanied by audio presentations can be accessed on the MTIS 2020 meeting website at: https://virtual.mtis2020.org/
About STOP 301:
INP104 utilizes Impel's propellant-enabled POD technology to conveniently and consistently deliver optimal doses of DHE deep into the vascular rich upper nasal space, an ideal target for efficient drug administration, particularly for the majority of patients with migraine who experience nausea and/or vomiting during an attack, which presents limitations for the use of oral therapies, including triptans, CGRP inhibitors and ditans as well as other non-specific acute migraine medications.
About Acute Migraine:
Further, evidence suggests that gastroparesis, delayed emptying of the stomach, is a prevalent feature in migraine that may delay or reduce the absorption of oral medications, including triptans, gepants and ditans. This means that acute medications can remain in the stomach for hours, delaying symptom relief, leading to loss of confidence (about future administration) and prolonged suffering for the current migraine attack.v
About Impel NeuroPharma:
IMPEL, POD and the IMPEL Logo are registered trademarks of Impel NeuroPharma, Inc. To learn more about Impel NeuroPharma, please visit our website at http://impelnp.com.
About Precision Olfactory Delivery or POD® Technology
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, Impel NeuroPharma has been able to demonstrate blood concentration levels for its investigational therapies that are comparable to intramuscular (IM) administration and can even reach intravenous (IV)-like systemic levels quickly, which could transform the treatment landscape for CNS disorders.
Importantly, the POD technology offers propellant-enabled delivery of dry powder and liquid formulations that eliminates the need for coordination of breathing, allowing for self- or caregiver-administration in a manner that may improve patient outcome, comfort, and potentially, compliance.
i Mayo Clinic. Migraine Symptoms & Causes. Last Accessed February 3, 2020.
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SOURCE Impel NeuroPharma