CERSCI THERAPEUTICS INCORPORATED — Department of Health and Human Services SBIR Phase II: NIDA

Description

Project SummaryAbstractPain is currently the most prevalentdisablingand costly health issue in our countryand this problem will continue to grow as our population agesThe societal impact of paine gtreatment costswork lossdecreased productivityco morbidities with addictiondepression and suicideexceeds the annual combined costs of heart diseasediabetesand cancerUnfortunatelythe drugs predominantly used to treat pain todayopioidsare addictive and require increasing dosages to obtain a given level of pain reliefThe difficulties posed by opioid use are magnified tremendously by the strong potential for addiction and abuseAccording to the Centers for Disease Control and Preventionapproximatelypeople die every day from overdoses related to prescription painkillersThese problems with opioidsand their limited efficacy over the longer term highlight the need for new pain medicinesThe scientific purpose of this project is to conduct studies to advance a promising new pain therapeuticCTbelonging to a novel chemotypepharmacological classinto first in human studiesOur innovation is the discovery of the first non metal based PN decomposition catalystThe past decade has demonstrated thatfree radicals contribute to pain andtheir interactions with nociceptive sensory neurons in the peripheral nervous system perturb nociceptive signalingOur goal is to move our lead moleculeCTinto the clinic through the investigational new drug enabling studies described in this proposalAs will be described in detail belowwe have amassed an impressive preclinical data package on this lead asset showing that the compound is highly efficacious in incisional and inflammatory pain modelsIn additionCThas a favorable oral disposition and a clean toxicology profile in a broad variety of assaysThis motivates us to pursue a direct to phase II proposal to conduct GLP toxicology studies to enable an IND application to the FDA to move this asset toward the clinic for trials for post surgical painWe believebased upon our experiencethat the CTdata packageexceedsand that the data favorably compares toeven the most rigorous criteria posed by pharma houses that have successfully advanced analgesics to marketThe majority of the proposed work constitutes dose escalation in order to set early human dose rangesand conductingessentially repeatingtoxicological studies under GLPand lastlymanufacturing CTunder GMPCollectively this is a rare opportunity to advance a novel therapeutic class into humans with a high probability for success due to extensive preclinicalde riskingstudies