According to a Seattle-based company, Impel NeuroPharma’s Trudhesa has been approved by the U.S Food and Drug Administration for migraine headache treatment.
Truhedsa uses Impel’s nasal spray system in the upper part of her nose to administer a migraine medication to her upper sinus cavity.
Trudhesa will be commercially launched by Impel in October. The company has already begun recruiting a sales team to promote it.
According to the company’s estimates, approximately 31 million Americans suffer from migraines. Many patients don’t get relief even with the existing medications.
“Pills don’t really work for a lot of patients so there’s a high unmet need,” Sheena Aurora, a neurologist and Impel’s vice president of medical affairs, told GeekWire in an interview this week.
The approval is the culmination of a vision that began more than ten years ago for John Hoekman, who co-founded the company in 2008 when he was a graduate student at the University of Washington studying medical devices.
Hoekman who was CEO from 2017 to 2017, is chief technology and innovation officer.
Impel has opted to bypass the traditional route of selling its product to larger pharmaceutical companies for final stages of clinical trials, and then commercialization.
Hoekman said that it was a challenge to move from being a technology company focused on devices to becoming a fully integrated pharmaceutical company. Adrian Adams, a biotech veteran who succeeded Jon Congleton in 2013, is now the company’s leader.
Impel raised $80 million in Washington state’s first IPO in April. After-hours trading on Thursday saw shares rise to over $33 and then fell back to $20/share Friday.
Hoekman was a graduate student and studied drug delivery to the upper nasal cavity. This area is home to a wealth of blood vessels. The upper nasal cavity is more likely to deliver drugs than the lower, which can allow agents to reach blood vessels and brain faster.
GeekWire’s Hoekman said that conventional nasal sprays are “ok if you have local rhinitis, or an allergy type thing and it only affects the nasal cavity.” It’s inefficient to try and get something else into your bloodstream, or your brain.
Impel’s Precision Ophthalmic Delivery (POD), which uses an external gas propellant to deliver drugs into the nasal cavities, was ultimately developed by Hoekman during his graduate studies. Hoekman said, “All that is required to get the drug to work is to put it in your nostrils and press a button.
Trudhesa is based on Dihydroergotamine Mesylate, a long-standing drug to treat migraines. DHE was traditionally administered via injection. There are also oral formulations which act slowly and through the absorption of food. Trudhesa administers DHE directly through the POD to the upper nose cavity.
The company recently published a phase 3 clinical study on 360 people with recurrent migraines. Trudhesa had no side effects and was well-tolerated. Moreover, around two-thirds (63%) of the patients reported pain relief after using Trudhesa within just two hours.
The company’s previous studies also revealed that the system achieved higher blood levels than Migranal (a Bausch Health DHE formula that targets the lower nose cavity). There are no studies directly comparing Trudhesa’s ability to beat pain against Migranal, which pulled in $104 million in revenue for Bausch last year.
Hoekman stated that in the early years of its existence, Hoekman partnered with a number of pharma companies, but these preclinical partnerships didn’t work out.
He said, “We learned a lesson about relying on partners to get you or do big licensing deals. If things go wrong or they change their focus or the economy is affected that could cause everything to fall apart fast.”
Hoekman said, “We made the decision that regardless of any other’s interest, or their willingness to work with, we would attempt to create this ourselves through approval.” We’ve been firm believers that one must be in control of their own fate.
This approval is good news for Impels, which has two agents that use the POD technology. A phase 2 proof of concept study will be initiated by the company later in the year to examine an agent that can cause agitation in autistic disorder. Data is expected to emerge around 2022. This second program will be for Parkinson’s disease.
These programs use existing drugs, but they deliver the drug through Impel’s PODS system to provide rapid action. Aurora stated that this “cleinically opens up a whole new realm.” Future formations will be able to get drugs faster or more conveniently to the target body.
Hoekman stated that “We have now assembled an essentially small pharmaceutical company team that was capable of pulling [Truhedsa] though the process. And hopefully, we’ll do it again.”
Before the IPO Impel raised $140 Million from various investors, including KKR and Norwest Venture Partners. 5AM Ventures, Vivo Capital and VenBio Partners.
Publited Fri, 3 Sep 2021 at 17:49:23 (+0000).