Impel NeuroPharma, a late-stage biopharmaceutical company focused
on the development and commercialization of transformative
therapies for patients living with central nervous system (CNS)
diseases with high unmet medical needs, announced today that it
will present data from eight scientific abstracts at the 63RD
American Headache Society Annual Scientific Meeting (AHS), taking
place virtually from June 3 – 6, 2021.
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
Stephen Shrewsbury, M.D., Chief Medical Officer at Impel
NeuroPharma. “By delivering optimal doses of DHE—a well-established
and effective migraine therapy—into the upper nasal space, INP104
leverages an untapped gateway for treatment administration that
could benefit absorption and migraine relief, especially among
people with migraine who have comorbid gastrointestinal disorders,
whether symptomatic or not.”
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 Carrie Dougherty, MD, FAHS, Associate Professor
of Neurology at MedStar Georgetown University Hospital. “This novel
delivery, targeting the upper nasal space, has the potential to
have a significant advantage in the management of migraine.”
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 U.S. Food and Drug Administration (FDA)
in January 2021 and has a Prescription Drug User Fee Act (PDUFA)
target action date of September 6, 2021. If approved by the FDA,
INP104 will become the first and only therapy to deliver DHE to the
vascular-rich upper nasal space using the POD technology, a novel
delivery system. The FDA has conditionally accepted a trade name of
TRUDHESA™.
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 the United States who had a
documented diagnosis of migraine with or without aura, with at
least two attacks per month for the previous six months. The study
evaluated 6,332 doses of INP104.
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, 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 and other 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.
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 the United States.3 Of the approximately 18
million diagnosed migraine patients, only four million are on
prescription treatment.4 While triptans account for almost 80
percent of migraine therapies, approximately 30 to 40 percent of
patients do not respond adequately to triptans and up to 79 percent
of the patients who do respond to triptans report being
dissatisfied with their current treatment and willing to try a new
therapy.5,6,7 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.8
About Impel NeuroPharma:Impel
NeuroPharma, Inc. is a late-stage pharmaceutical company focused on
utilizing its proprietary technology to develop and commercialize
transformative therapies for people suffering from diseases with
high unmet needs, with an initial focus on diseases of the CNS. The
Company’s strategy is to rapidly advance its product candidate
pipeline that pairs its proprietary Precision Olfactory Delivery
(POD®) system with well-established therapeutics, including INP104
for the acute treatment of migraine, INP105 for the acute treatment
of agitation in patients with autism, and INP107 for OFF episodes
in Parkinson’s disease.
Cautionary Note on Forward-Looking
StatementsThis press release contains "forward-looking"
statements within the meaning of the safe harbor provisions of the
U.S. Private Securities Litigation Reform Act of 1995, including,
but not limited to, timing of approval of Impel’s NDA for INP104
(proposed trade name TRUDHESA™) and of Impel’s other regulatory
submissions, timing of announcements of clinical results and
clinical development activities of its product candidates,
potential benefits and market opportunities of INP104 and its other
product candidates and its cash runway. Forward-looking statements
can be identified by words such as: “believe,” “may,” “will,”
“potentially,” “estimate,” “continue,” “anticipate,” “intend,”
“could,” “would,” “project,” “plan,” “expect” or the negative or
plural of these words or similar expressions. These statements are
subject to numerous risks and uncertainties that could cause actual
results and events to differ materially from those anticipated,
including but not limited to, Impel’s ability to obtain and
maintain regulatory approval of INP104 and its other product
candidates, its ability to execute its commercialization strategy
for INP104 its ability to develop, manufacture and commercialize
its product candidates including plans for future development of
its POD devices and plans to address additional indications for
which Impel may pursue regulatory approval, whether results of
preclinical studies or clinical trials will be indicative of the
results of future trials, and the effects of COVID-19 on its
clinical programs and business operations. Many of these risks are
described in greater detail in Impel’s filings with the Securities
and Exchange Commission. Any forward-looking statements in this
press release speak only as of the date of this press release.
Impel assumes no obligation to update forward-looking statements
whether as a result of new information, future events or otherwise,
after the date of this press release.
Contact:Lance BuckleyLippe Taylor
Grouplbuckley@lippetaylor.com917-439-2241
Impel, POD and the Impel logo are U.S. registered trademarks of
Impel NeuroPharma, Inc. To learn more about Impel NeuroPharma,
please visit our website at https://impelnp.com/.
1. Silberstein SD, et al. Headache. 2020;60:p 47/col 2/para 1.
2. Mayo Clinic. Migraine Symptoms & Causes. Last Accessed
February 3, 2020. 3. Migraine Research Foundation. Migraine Facts.
Last Accessed February 3, 2020. 4. Data on file.5. Smitherman TA,
Burch R, et al. The prevalence, impact, and treatment of migraine
and severe headaches in the United States: a review of statistics
from national surveillance studies. Headache. 2013
Mar;53(3):427-366. Leroux E, Buchanan A, et al. Evaluation of
patients with insufficient efficacy and/or tolerability to triptans
for the acute treatment of migraine: A systematic literature
review. Adv Ther. 2020 Dec;37(12):4765-4796.7. Bigal M, Rapoport A,
et al. Satisfaction with current migraine therapy: experience from
3 centers in US and Sweden. Headache. 2007 Apr;47(4):475-98. Aurora
S, et al. Cephalalgia. 2013; 33:408-415; Tokola RA et al. Br J Clin
Pharmacol. 1984. 18:867-871; Volans GN. Clin Pharmacokinet. 1978
3:313-318
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