Seattle-based Impel Neuropharma has been working for five years to show it can quickly deliver drugs through the nose, directly to the brain, for the treatment of central nervous system disorders. The animal data so far has been encouraging, but now the company has got key confirmation that it can do its thing in human beings.
Impel, a University of Washington spinoff, is announcing today that it has gotten those positive results from a study of seven patients, which was supported by one of its pharmaceutical collaborators. Full details are being saved for a peer-reviewed publication, but Impel chief scientist John Hoekman says that the company’s nose-to-brain drug delivery device was able to propel a small peptide molecule deep into the upper nasal passages and to the brain stem at an “order of magnitude” greater concentration than a conventional nasal spray.
The study enrolled research subjects at the Lovelace Respiratory Research Institute in Albuquerque, NM, Hoekman says. Researchers used an off-the-shelf peptide (not an actual drug candidate), attached to a radioactive tracer molecule, and used noninvasive SPECT imaging technology to confirm that the drug was getting delivered to the brain. Volunteers in the study were able to self-administer the compound through the nose, and researchers saw it get delivered to the destination within 10 to 20 minutes, Hoekman says.
“This is a pretty seminal study for us,” says Impel CEO Michael Hite. “The impact to the field of nose-to-brain delivery in general is going to be pretty significant.”
The idea at Impel, which I first wrote about for Xconomy in August 2008, is to noninvasively get drugs deep into the anatomy of the skull, where nasal sprays can’t go. Most nasal sprays don’t propel drugs anywhere close to the upper nasal passage—the only place in the body where primary neurons are possibly accessible to the outside environment. Impel’s device delivers a pressurized, rotational flow of aerosol to reach those neurons.
This kind of technology could be valuable for a number of different patient groups with central nervous system disorders. The body’s blood-brain barrier stops many drugs from getting where they need to go in the brain. Oral pills that are effective for central nervous system disorders, like, say, Parkinson’s disease, take some time to be absorbed thoroughly into the blood, and they can cause side effects when absorbed throughout the body. A nose-to-brain delivery device could, in theory, get an effective pain reliever to work more quickly for patients in need of something fast, and do it safely by minimizing the amount that gets absorbed into the bloodstream. It also could be convenient for patients, especially when compared with injectable treatment options.
Impel has gotten this far on about $1.5 million in investment from friends, family, and angel investors, plus about $3.5 million in grants from the National Institutes of Health, Department of Defense, and the state of Washington’s Life Sciences Discovery Fund. The company has struck a series of small research collaborations with seven pharmaceutical and medical device manufacturers that are developing central nervous system drugs, Hite says.
Of course, Impel isn’t the only group seeking to effectively deliver biologics through the nose and to the brain. UW researcher Suzanne Craft made headlines a couple years ago when she led a study which suggested that insulin—a well-known peptide used for treating diabetes—might be an effective option for treating Alzheimer’s disease when delivered through a nasal spray.
The next step at Impel will be to show biotech and pharma partners the data at the Biotechnology Industry Organization convention in Chicago, Hite says. The goal will be to strike a bigger type of drug/device development collaboration, which would involve an active drug candidate at a pharma company that is being tested in a typical early-stage clinical trial to assess safety, absorption, and drug distribution through tissues, Hite says.
Impel believes its device can work with a variety of biologic drugs—peptides and larger protein molecules. The company’s animal trials have suggested it can deliver a wide variety of biologics in different shapes and sizes, Hoekman says.