Impel Awarded Phase II SBIR Grant to Develop Pre-Clinical POD Devices

Development of neurological and mental health drugs often requires pre-clinical testing in multiple pre-clinical models to demonstrate efficacy and safety and to elucidate mechanisms. Drug delivery to the central nervous system (CNS) to target neurological diseases is particularly problematic because the blood-brain barrier (BBB) prevents most compounds from reaching the brain from the blood. While other methods of pre-clinical CNS delivery exist, these methods are invasive, not precise, or are not easily translated to clinical use. Overall, the difficulty of distributing drugs to the CNS severely limits drug development efforts.

Impel NeuroPharma has long recognized that in vivo pre-clinical evaluation of potential therapeutic candidates using the nose-to-brain route is one of the largest hurdles to overcome, largely due to a lack of standardized, reproducible method of nasal delivery targeting the olfactory region.  Impel’s novel Precision Olfactory Delivery (POD) device allows non-invasive, targeted delivery of drugs and biologics to the CNS using the nose-to-brain route of the olfactory region to bypass the BBB. Applying the principles of the POD device to pre-clinical studies is ideal because it precisely targets the upper nasal cavity in a variety of pre-clinical models.

Impel was recently awarded a two-year $1.5M Phase II Small Business Investigational Research (SBIR) grant from the National Institute of Mental Health to develop standardized, robust and affordable devices for use in pre-clinical studies that makes the technology more accessible to researchers everywhere. The larger objective of the Phase II project is to increase the number of CNS therapeutics investigated via the nose-to-brain pathways; as more therapeutics are investigated, more CNS disease treatments should become available to the public.

In 2012, Impel was awarded a two-year Phase I SBIR grant to demonstrate the feasibility of developing standardized pre-clinical versions of the POD devices.  Impel was successful in showing that pre-clinical nose to brain delivery devices and test methods could be mass produced as research tools.

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John Hoekman, Ph.D., Impel’s Chief Scientific Officer, is the Principal Investigator on the grant.  Dr. Hoekman was inspired to investigate the influence of regional deposition in the nasal cavity on nose-to-brain transport, which lead to the first early versions of the pre-clinical POD devices being constructed during his doctoral research at the University of Washington.  His research demonstrated that delivery to the upper nasal cavity significantly improved drug concentrations in the brain in amounts that could not be accounted for by distribution of the drug from the blood, helping to establish the nose-to-brain pathway as a viable drug delivery route.

For this Phase II SBIR program, Impel will be assisted by Drs. William Frey and Leah Hanson at HealthPartners Neuroscience Research, in St Paul, MN who are pioneers in nose-to-brain drug delivery.  In one of the final objectives if the grant, Impel will bring together leading pre-clinical nose-to-brain researchers from across the country at Dr. Frey’s lab to conduct training with the device.

Impel collaborated on the grant application with HIREtech. “Getting funding for this project is very gratifying for several reasons,” said Jacob Setterbo, Ph.D., Director of Grants at HIREtech, who helped draft, organize, and submit the application. “Not only does this proposed product benefit Impel, but it also benefits researchers by providing more affordable pre-clinical tools — eventually we hope it will also benefit patients who will receive newer, more effective therapeutics developed using this novel nose-to-brain pathway.”

This grant is a strong statement of support for the ongoing work of the National Institute of Mental Health (NIMH) to build better research tools for diseases of the brain.  The SBIR program allows small companies like Impel to pursue additional research programs without hindering their lead commercial and R&D efforts – in an environment of scarce resources, many of these programs would not be able to proceed without such funding, which would be a lost opportunity for both researchers and patients.

Impel’s ultimate goal for the grant project is to commercialize pre-clinical POD devices and make them available to researchers globally.  Impel and the NIMH share a goal of improving the productivity of neuroscience researchers by providing the best tools for evaluating promising brain and CNS therapeutics.  Once commercialized, pre-clinical POD devices could become standard equipment in neuroscience drug development labs around the world.