Tool for non invasive delivery of central nervous system drug candidates

DESCRIPTION provided by applicant Impel NeuroPharma is developing a nose to brain drug delivery device to enable drugs to bypass the blood brain barrier BBB in humans This Phase II SBIR aims to develop robust non custom and affordable devices for use in preclinical studies that makes the technology more accessible to researchers everywhere During this project Impel will be assisted by Drs William Frey and Leah Hanson at HealthPartners Neuroscience Research who are experts in nose to brain drug delivery Development of neurological and mental health drugs often requires preclinical testing in multiple animal 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 blood While other methods of animal 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 severel limits drug development efforts Impelandapos 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 The POD device is ideal for preclinical animal studies because it precisely targets the CNS without disrupting the BBB and is scalable across a spectrum of animal models Impel has promising POD device data in multiple preclinical models and in humans Commercial interest in this product has been confirmed by large pharmaceutical companies and academic laboratories who have already set up agreements to use the POD device This Phase II project will greatly decrease POD device prices make them more accessible and increase the number of CNS therapeutics investigated via the nascent and promising nose to brain pathway As more therapeutics are investigated more CNS disease treatments should become available to the public In Phase I feasibility was demonstrated and the primary milestone was achieved as Impel developed primarily molded versions of POD devices that are not significantly different from hand made prototypes e g olfactory region dose deposition was less than different than bench use POD devices Additionally testing tools were created for continued development including preclinical nasal models a deposition testing stage and an impact force testing apparatus Impel has confirmed commercial interest in the proposed Phase II project from academics and industry including multiple research labs and a large pharmaceutical company In this Phase II project mouse rat and primate POD devices will be refined Impel will develop high volume molds and a semi automated assembly process Aim perform in vitro validation Aim perform in vivo validation Aim develop professional training materials Aim and optimize training materials so target end users can successfully deposit drugs in vivo Aim This project will take two years to complete PUBLIC HEALTH RELEVANCE Impel NeuroPharma is developing a nose to brain drug delivery device to enable drugs to bypass the blood brain barrier BBB in humans The goal of this Phase II SBIR is to develop robust and affordable preclinical animal versions of this device and a stand alone training program that makes the technology more accessible to researchers everywhere These preclinical research tools should enable swifter clinical translation of new pharmaceuticals as researchers will be using an administration method that has a direct clinical parallel These non invasive tools should also enable both academic and industrial researchers to investigate more drugs to treat neurological and mental health diseases