医学交流课件：Paul D Shanghai for China.pptxVIP

Pearl Co-SuspensionTM Metered Dose Inhalers Platform and PT010 Overview08/09 July 2016COPD and Asthma – Progressive DiseasesRequire Escalating Interventions with Decreasing Pulmonary FunctionFemale non-smokers(similar trends for males, and smokers)Lange et al., NEJM 339 (1998) 1194Fletcher and Peto, BMJ, 1977, Rennard and Vestbo, PATS, 2008Price et al. StudyPrice et al. Resp Med 2011; 105: 1457-66MDI Formulation ChallengeMDI SuspensionMicronized Drug CrystalsSettlingDrug-Drug interactionCohesionAdhesionPorous Particles: Construction and PropertiesExtensive non-clinical and clinical safety dataDistearoylphosphatidylcholineInstantly collapse at airway temperature and humidityStable at room temperature Aerodynamically LightConstructionPerforated ScaffoldingStructureAdapted from Vehring R et al. Langmuir 2012; 28: 15015?23; Non-clinical and clinical safety evidence on file at PearlCONFIDENTIALParticle Types in Co-suspension MDIs4g~1.4g/cc~0.25 g/ccDrug CrystalsStable, purePorous ParticlesStable, buoyantCo-SuspensionTM: Foundation of a PipelineRapid and simple transition across productsMonotherapyDual CombinationTriple CombinationHFA suspension droplet*Not drawn to scale. Actual morphology may varyMonotherapy Co-SuspensionTM: Dose RangingTunability and precision at nanogram dose levelsDrug Fine Particle MassAdapted from Noga B et al. Presented at ERS 2013Dual Co-SuspensionTM – In Vitro Dose RangingNo ‘co-formulation’ effectAdapted from evidence published by Noga et al, ERS 2013; In vitro laboratory test data on file at Pearl.CONFIDENTIALCo-SuspensionTM: Mono, Dual, and TripleNo evidence of interaction between drug typesReisner et al, ERS 2014: slide from podium presentation.CONFIDENTIALTriple Co-SuspensionTM – In Vitro Dose Ranging Budesonide Doses with Fixed Backdrop of LAMA and LABAPT010PT003Reisner et al, ERS 2014: slide from podium presentation.CONFIDENTIALBudesonide PK from Triple – Dose Proportional Drug DeliveryEvidence supports progression of triple combination