Impel NeuroPharma announces commercial milestones and first-in-human use of Precision Olfactory Delivery (POD) technology

June 13, 2012—SEATTLE, WA—Impel NeuroPharma, a medical device company developing a novel drug delivery device that enables drugs to bypass the blood-brain barrier (BBB) using direct nose-to-brain delivery today announced a set of important milestones in its drive to commercialize its POD technology.

The key milestones announced today are:
1. Successful first-in-human pilot study of the POD technology,
2. Three (3) collaborations with leading pharmaceutical companies to pursue applications of the POD technology in three different CNS therapeutic applications, and
3. Award of a Small Business Investigational Research (SBIR) grant from the National Institutes of Health (NIH) and National Institute of Drug Abuse to evaluate a first-in-class biologic analgesic.

The results of the first-in-human study using the POD technology will be discussed at the 2012 BIO International Convention in Boston, MA on June 18-21. The study showed a 2:1 overall preference for the POD technology over conventional nasal spray devices. “This is an encouraging result which indicates the POD technology can be easily utilized in clinical research and incorporated into commercial drug-device combination products.” said John Hoekman, PhD, Impel NeuroPharma’s Chief Scientific Officer. “We have designed the POD device with the end user in mind. We want to ensure it is easy to use for both patients and clinical investigators.”

The collaborations announced today are the direct result of Impel NeuroPharma’s focus on incorporating its drug delivery technology into meaningful therapeutic initiatives of pharmaceutical companies. One of Impel NeuroPharma’s current collaborations is designed to demonstrate the effectiveness of the POD technology in humans. Results from this human study will be presented this fall.

“We are extremely pleased by the response of the pharmaceutical industry to our inventive nose-to-brain delivery technology. These collaborations validate Impel NeuroPharma’s technology in a wide range of therapeutic indications and CNS agents. Our goal is to collaborate with pharmaceutical companies who have CNS agents that can benefit from nose-to-brain delivery. Our next wave of projects will continue tobroaden the range of therapeutic applications in which we can provide the greatest impact,” stated Michael Hite, Impel NeuroPharma’s Chief Executive Officer.

Impel NeuroPharma has been awarded a Phase 1 SBIR grant of $150,000 which will be used to evaluate a novel biologic analgesic therapeutic. Nose-to-brain delivery may enable the delivery of analgesic therapeutics that have fewer side effects and have lower potential for abuse. Dr. Hoekman will serve as the PI for the grant. Dr. Hoekman currently serves as the PI on a Phase 2 SBIR grant received in 2011 from the Department of Defense and as an investigator on the commercialization grant from the Life Science Discovery Fund (LSDF) received in 2011. Impel NeuroPharma has received over $1.9 million in grants since its inception.

The announced milestones build upon Impel NeuroPharma’s recent accomplishments as it moves rapidly toward the commercialization of its POD technology.

About Impel NeuroPharma:
Impel NeuroPharma Inc. is a medical device company developing a novel drug delivery device that enables drugs, including biologics, to bypass the blood-brain barrier (BBB) using direct nose-to-brain delivery.

About the Precision Olfactory Delivery Technology:
Impel NeuroPharma’s Precision Olfactory Delivery (POD) device delivers aerosolized drugs to the upper nasal cavity where they are directly transported into the brain, effectively bypassing the blood-brain barrier. The POD device enables molecules to become therapeutics that were previously unable to cross the blood-brain barrier, and often allows less drug volume to be utilized, lowering plasma exposure and reducing systemic side effects. The POD device is compatible with liquid and powder formulations of both small molecule and biologic drugs.
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