Lindmik research - cutting edge information of drug delivery technology (3)
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Impel neuropharma is a pioneer in upper nasal drug delivery in the field of CNS therapy.
(source: Network)

Impel neuropharma, located in Seattle, was founded in 2008 and landed on NASDAQ in 2021 with the stock code impl. In 2021, FDA approved trudhesa, the company's first listed variety ® (dihydroergotamine methanesulfonate), used to treat migraines, making impel one of the commercialized biotechs.

Impel focuses on CNS therapy
Impel focuses on the field of CNS treatment, especially for CNS diseases in acute attack stage, which requires fast onset and convenient use of drugs. The effect of oral administration is slow, the compliance of injection patients is poor, and the use is not convenient enough, which is often limited to hospital use. For drug delivery of CNS diseases, nasal administration has natural advantages, which can pass through the blood-brain barrier, fast onset, easy to use, convenient to carry, etc.

Nose to brain pathway was first confirmed in animals in 1985. The traditional nasal delivery route is mainly delivery to the lower nasal cavity, and the lower nasal delivery technology has been developed very mature, and many drugs have been approved for marketing, such as xsail (sumatriptan nasal inhalation powder), migranal (dihydroergotamine), tosymra (sumatriptan nasal spray), etc.

Innovative nasal delivery pod (precision olfactory delivery) technology platform
However, there are deficiencies in the route of lower nasal administration. For example, due to the downward drip from the nasal cavity, the drug absorption is reduced and the mucosa is cleared. The olfactory nerve pathway in the upper nasal cavity is more abundant, which is an ideal drug delivery target. However, the usual delivery technologies, such as nasal sprays, can only deposit less than 5% of the drugs in the upper nasal cavity, and can not continuously or effectively deliver enough drugs to the disease site.

Based on this, impel neuropharma has developed an innovative nasal drug delivery technology platform, pod (precision olfactory delivery) technology platform, that is, drug delivery through the upper nasal path. The upper nasal cavity is rich in blood vessels, which can provide continuous drug delivery and improve drug utilization.

The pod system is a hand-held, manually operated, gas ejection device that delivers active ingredients to the upper nasal cavity.
(source: Network)
Developed varieties
Based on POD technology platform, the company has developed three varieties, one of which has been listed.
(source: Network)

Trudhesa ® (dihydroergotamine mesylate) (code named inp104) is an improved new drug developed by pod delivery technology. The active ingredient is dihydroergotamine mesylate, an old drug, which is used to treat adult acute migraine with or without aura. The specification is 0.725mg/spray. It was approved by FDA in September 2021. Inp105 (olanzapine) is currently in phase 1 for the treatment of acute agitation. Inp107 (levodopa / carbidopa compound) is currently in phase2a for the treatment of off events of Parkinson's disease.Trudhesa(INP104)


Dihydroergotamine mesylate is the standard treatment for migraine at present. At present, there are mainly oral and injection types, but the oral effect is slow. Especially for acute migraine, although the injection type has a fast effect, it is often limited to be used by professionals and hospitals, which is very inconvenient for patients in acute stage. Trudhesa solves this problem. The plasma concentration and time after taking medicine are equivalent to that of injection.

Mean plasma DHE concentration and inp104 dose after a single trial
(source: Network)

In addition, data from the approved key open label clinical phase 3 trial (stop301 study) (nct03557333) showed that headache disappeared in 38% of patients and relieved in 66% of patients 2 hours after the first administration of inp104. Among the patients with headache disappearance, 93% could last 24 hours without headache and 86% could last 48 hours without headache.


Our point of view
Improved new drugs are the stage for the great development of preparations and drug delivery technology. In order to quickly go on the market and seize the market, the new molecular entity developed by the original research company can save development time by choosing more traditional preparation technology at the beginning. However, it contains a clinical requirement, that is, in view of the defects of traditional delivery technology, drug delivery paths and preparations with more clinical value can be developed.


reference material:
https://impelpharma.com/treatments/migraine-treatment/
John Hoekman, Sutapa Ray, Sheena K Aurora, and Stephen B Shrewsbury. The Upper Nasal Space—A Novel Delivery Route Ideal for Central Nervous System Drugs: Review Drug Delivery.
https://clinicaltrials.gov/ct2/show/results/NCT03557333?term=INP104&draw=2&rank=1
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