EXTEND BIOSCIENCES INC — Department of Health and Human Services SBIR Phase I: 103

Description

Project Summary Neuropathy is an acquired disease that can lead to debilitating chronic pain affectingtoof the general populationAmong patients with symptomatic neuropathysleep disturbancesanxiety and depression are commonnegatively impacting quality of lifeDiabetes is a leading cause of neuropathy and is expected to become more prevalent as the incidence of diabetes increasesChemotherapy induced peripheral neuropathyCIPNis a serious side effect of numerous common chemotherapeuticsUnfortunatelythere are no disease modifying therapeutics that can prevent neuropathy or regenerate nervesWhile there are palliative treatments for pain symptomsthey are effective in less thanof patients and use of opioids is restricted for the most severe cases of chronic pain as they can lead to addictionClearly there is a need for safeeffectivewelltolerated drugs to treat painful neuropathy by halting or reversing the underlying pathology of the diseaseOne promising approach to treating painful neuropathy without opioids is the use of ghrelinaamino acid acylated peptide hormoneHoweverit has a short half life and must be delivered via a constant intravenous infusion to have a therapeutic effectExtend BiosciencesandaposD VITylation platform technology is truly enabling for small peptide based therapeutics that are rapidly cleared from the bloodstream by renal filtrationOur platform harnesses the naturally long half life of vitamin D and its dedicated binding proteinVDBPWhen our vitamin D molecule is conjugated to a biological therapeuticit dramatically improves the half life and bioavailability of the drugIn additionuse of the technology should also allow the drug to be self administered by subcutaneous injectionThis would be of significant benefit to patientsIn our preliminary experimentswe applied DVITylation to this promising peptide to generate EXTas a therapeutic for neuropathyPharmacokinetic data show an extended half life compared to the native peptideIn this Phase I SBIRwe propose to test the efficacy of EXTin a cell based model of neuropathy as well as in animal models of CIPN and diabetesinduced neuropathy Narrative Neuropathy is an acquired disease that can lead to debilitatingwidespread and chronic pain that affectstoof the general populationCurrent treatments attempt to relieve the pain without treating the underlying cause of the painExtend Biosciences proposes a novel long acting peptide hormone therapeutic that will prevent damage to the neurons and maintain and or restore neuron functionality