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ORYZON Announces Submission of Phase III Protocol to FDA to Initiate PORTICO-2 Trial of Vafidemstat in Borderline Personality Disorder (BPD) Patients

PORTICO-2 designed to validate vafidemstat’s efficacy in reducing aggression in BPD patientsPrimary endpoint: STAXI-2 Trait Anger (patient-reported)Key secondary endpoint: Overt Aggression Scale-Modified (OAS-M) (clinician-rated)Additional secondary endpoints will assess global clinical improvementProtocol finalized following FDA guidance and input from leading US psychiatry expertsUpcoming KOL webinar to discuss trial design and the urgent medical need in BPD MADRID and CAMBRIDGE, Mass., June 2

articleOryzon Genomics SaJune 23, 20258/company/oryzon-genomics-sa/news/oryzon-announces-submission-of-phase-iii-protocol-to-fda-to-initiate-portico-2-trial-of-vafidemstat-in-borderline-personality-disorder-bpd-patients
ORYZON Announces Submission of Phase III Protocol to FDA to Initiate PORTICO-2 Trial of Vafidemstat in Borderline Personality Disorder (BPD) Patients

About this update from Oryzon Genomics Sa

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BPDclinical trial protocolbiopharmaceutical companyFDAunmet medical needPhase IIIclinical improvementspatientsPORTICO