The U.S. Food and Drug Administration has approved Impel NeuroPharma’s Trudhesa for the treatment of migraine, Seattle company Announced on friday.
Truhedsa uses Impel’s upper nasal spray system to deliver migraine medications to the upper nasal cavity.
Impel is expected to commercially launch Trudhesa in early October and has begun recruiting sales staff for marketing.
According to the company, approximately 31 million adults in the U.S. suffer from migraines, and many patients have not been completely relieved after using existing medications.
“Pills are not really effective for many patients, so there is a huge unmet need,” Hina AuroraThe neurologist and Impel’s vice president of medical affairs told GeekWire in an interview this week.
Approval is the culmination of a vision that began more than ten years ago John HawkmanIn 2008, he co-founded the company while studying for a medical device graduate student at the University of Washington.
“When I founded the company, I never really expected to bring the product to the market,” said Hoekman, who had been the CEO until 2017 and is now the chief technology and development officer.
Impel bypasses the traditional approach of handing over its products to larger pharmaceutical companies for clinical trials and the final stages of commercialization.
Hoekman said, “It is a huge challenge to transform from a company focused on equipment technology to a fairly integrated pharmaceutical company.” The company is led by a biotech veterinarian. Adrian Adams Who took over Jon Congleton last year.
Impel raised $80 million in its first IPO in Washington State in April. After the stock market closed on Thursday, the stock price soared overnight and fell back on Friday. The trading price was about US$20 per share.
As a graduate student, Hoekman studied how to deliver drugs to the upper nasal cavity, where there are abundant vascular beds. Compared to passing through the lower part of the nose with conventional nasal sprays, the drug travels from the upper nose to the blood and brain faster.
Hoekman told GeekWire that traditional nasal sprays “if it is a local rhinitis or allergic type of thing, you only affect the nasal cavity, it’s fine.” “But for more things, you try to get it into your blood or brain, which is very inefficient.”
Hoekman’s postgraduate research eventually led to Impel’s precision olfactory transmission (POD) system, which uses an external gaseous propellant to deliver drugs deep into the upper nasal cavity. “All you have to do is put them in your nose, press a button, and the medicine will go where it needs to go,” Hawkman said.
Trudhesa is based on a decades-old migraine drug dihydroergotamine mesylate (DHE). DHE is traditionally administered by injection, oral formulations are slowly absorbed through the intestines, and conventional spray formulations. Trudhesa delivers DHE directly to the upper nasal cavity via POD.
The company recently released Phase 3 360 people clinical study Recurrent migraine. Studies have shown that Trudhesa is generally well tolerated and has no serious side effects. In addition, about two-thirds of patients self-reported pain relief within two hours after using the spray.
In a previous study, the company also showed that their system achieved a higher blood concentration than Migranal, which is a DHE formula of Bausch Health that targets the lower nasal cavity.
Hawkman said that the company worked with many pharmaceutical companies in the early years, “It was very, very small, and I didn’t know what we were doing.” But these pre-clinical collaborations were not smooth.
“We learned a quick lesson if you rely on your partners-even though they may be great-to acquire you or make a big licensing deal, if something goes wrong, or their attention changes, or What happens is that the economy may collapse quickly,” he said.
“We decided that regardless of other people’s interest or whether they are willing to work with us, we will try to develop our own through approval,” Hoekman added. “We have always believed that you must be able to control your own destiny.”
This approval bodes well for the other two agents in the Impels pipeline that utilize POD technology. The company will launch a second phase proof-of-concept study on autism agonists later this year, and data is expected to appear in 2022. The second project is for Parkinson’s disease.
Both projects utilize existing drugs, but provide rapid action through Impel’s POD system. “Clinically speaking, this opens up a whole field,” Aurora said, opening the door to future formation to deliver drugs to goals in the body faster or more conveniently.
“We have now formed a team, which is essentially a [Truhedsa] Throughout the process, I hope we can do this again,” Hoekman said.
Prior to the IPO, Impel had raised $140 million from investors including KKR, Norwest Venture Partners, 5AM Ventures, Vivo Capital, and VenBio Partners.