Development of NH101: A Simple and Efficient Outpatient Dry Powder Amphotericin B-DryNeb(dry powder nebulizer) for Treatment of Susceptible and Multidrug Resistant Aspergillus/ Fungal Infections
Development of NH101: A Simple and Efficient Outpatient Dry Powder Amphotericin B-DryNeb(dry powder nebulizer) for Treatment of Susceptible and Multidrug Resistant Aspergillus/ Fungal Infections
批准号:
10484014
负责人:
Matthew Reed
金额:
$115.83万
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
已结题
起止时间:
2020-02-15 至 2024-06-30
关键词:
AerosolsAllergic Bronchopulmonary AspergillosisAmphotericin BAntifungal AgentsAntifungal TherapyArtsAspergillusAsthmaAustraliaBreathingCharacteristicsChronic Obstructive Pulmonary DiseaseClinicClinicalClinical ResearchClinical assessmentsCystic FibrosisDevelopmentDevicesDiseaseDoseDrug KineticsEnsureFormulationFumigationFutureHumanIn VitroInhalationInhalatorsInvestigational New Drug ApplicationItraconazoleLegal patentLungLung TransplantationLung diseasesLung infectionsMedicalMetered Dose Inhaler DeviceMorbidity - disease rateMulti-Drug ResistanceMycosesNebulizerNo-Observed-Adverse-Effect LevelOrphanOutpatientsParticle SizePathway interactionsPatientsPharmaceutical PreparationsPhasePhase I/II TrialPositioning AttributePowder dose formProductionPublic HealthRattusReportingRodentSafetySalesSiteSmall Business Innovation Research GrantSystemTestingTherapeuticToxicologyTriazolesasthmaticcommercializationcystic fibrosis patientsdesignefficacy studyefficacy testingfirst-in-humanguinea pig modelmanufacturing processmilligrammortalitynovelprogramsprototypepulmonary functionresistant Aspergillusresistant strainsafety testingscale upsuccess
中文摘要
项目摘要
本项目的总体目标是在第一阶段SBIR研究的成功基础上,
Progress NH 101:与DryNe B ™组合的阿替霉素B(AMB)的纯(纯)干粉,
一种新型的干粉雾化器进入“临床就绪”状态。该计划的结果将使一个
I期临床研究(AUS),与FDA就NH 101 505(B)(2)监管进行合作
批准途径,最终,研究性新药(IND)申请和II期
过敏性支气管肺炎(ABPA)的临床概念验证(POC)有效性试验。
NH 101(AMB-DryNeb™)通过针对常见的和未满足的医疗需求,
三唑(抗真菌类,例如,伊曲康唑)多药耐药(MDR)曲霉菌株
肺部感染的部位。NH 101最初将专注于囊性纤维化(CF)和哮喘相关性
ABPA是一种罕见的孤儿和严重疾病,通常与未满足的医疗需求相关,
估计2.5%的哮喘患者(约500万)和15%的CF患者(约20,000)。该项目将
实现三个主要目标:1)将DryNeb™提炼、测试和生产到临床级规模,
2)按比例放大并以Kg规模配制AMB,以及3)首次在人体内进行使能重复剂量
GLP毒理学研究。
英文摘要
Project Summary
The overall objective of this project is to build on the successes of our Phase I SBIR studies to
progress NH101: a pure (neat) dry powder of amphotericin B (AMB) combined with the DryNeb™,
a novel dry powder nebulizer to “clinic ready” status. The results of this program will enable a
Phase I clinical study (AUS), engagement with the FDA on the NH101 505(b)(2) regulatory
approval pathway, and ultimately, an Investigational New Drug (IND) application and Phase II
clinical proof of concept (POC) efficacy testing in Allergic Bronchopulmonary Aspergillosis (ABPA).
NH101 (AMB-DryNeb™) satisfies multiple unmet medical needs by targeting common and
triazole (antifungal classes, e.g., itraconazole) multidrug resistant (MDR) strains of aspergillus at
the site of lung infection. NH101 will initially focus on cystic fibrosis (CF) and asthma-associated
ABPA, a rare, orphan and severe disease of unmet medical need commonly associated with an
estimated 2.5% of asthmatics (~5 million) and 15% (~20,000) of CF patients. This project will
achieve three primary objectives: 1) refine, test, and produce the DryNeb™ to clinical-grade scale,
2) scale up and formulate AMB at Kg scale, and 3) perform a first in human-enabling repeat dose
GLP toxicology study.
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Development of NH101: A Simple and Efficient Outpatient Dry Powder Amphotericin B-DryNeb(dry powder nebulizer) for Treatment of Susceptible and Multidrug Resistant Aspergillus/ Fungal Infections
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批准号:9909193
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项目类别:
-
资助金额:$29.91万
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财政年份:2020
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负责人:Matthew Reed
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依托单位:
Development of NH101: A Simple and Efficient Outpatient Dry Powder Amphotericin B-DryNeb(dry powder nebulizer) for Treatment of Susceptible and Multidrug Resistant Aspergillus/ Fungal Infections
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批准号:10654834
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项目类别:
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资助金额:$56.43万
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财政年份:2020
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负责人:Matthew Reed
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依托单位:
海外基金