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靶向VAP-1的抗体BTT1023医治胆
靶向VAP-1的抗体BTT1023医治胆
26Augustat2.30p.m.(EET)TheUnitedStatesFoodandDrugAdministration(FDA)hasgrantedOrphanDrugDesignationintheUnitedStatesforBiotie'sBTTdrugcandidateforthetreatmentofprimarysclerosingcholangitis(PSC).PSCisachronicandprogressivefibroticliverdiseaseforwhichtherearecurrentlynoFDA-approvedtreatments.
BTTisafullyhumanmonoclonalantibodytargetingVascularAdhesionProtein-1(VAP-1),anditiscurrentlybeingstudiedforPSCinaPhase2astudy(theBUTEOstudy).TheBUTEOstudyisconductedinpartnershipwiththeUniversityofBirmingham,UK,andissupportedbygrantfundingawardedbytheUK'sNationalInstituteforHealthResearch(NIHR)EfficacyandMechanismEvaluationProgramme,egrantholderandCo-InvestigatorforthestudyisProfessorDavidAdams,DirectoroftheNIHRBiomedicalResearchUnitinLiverDiseaseandCentreforLiverResearchattheUniversityofBirmingham.
Thetwo-stagestudydesignforBUTEOincludesapre-plannedinterimanalysis,andbasedoncurrentestimates,itisexpectedthattherequisitenumberofpatientswillhavebeentreatedtoenabletheinterimanalysisinthefirsthalfof.
InMarch,otieretainsfullrightstoBTT.
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