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

Core Insights - Oryzon Genomics has submitted the clinical trial protocol for its Phase III PORTICO-2 trial to the FDA to evaluate vafidemstat in patients with Borderline Personality Disorder (BPD) [1][2] - The PORTICO-2 trial aims to address the significant unmet medical need in BPD, particularly focusing on aggression as a primary endpoint [2][5] - Vafidemstat is an orally active LSD1 inhibitor with a favorable safety profile and potential applications in other neurodevelopmental and neurodegenerative disorders [1][6] Company Overview - Oryzon Genomics is a clinical-stage biopharmaceutical company based in Barcelona, Spain, specializing in epigenetics and personalized medicine for CNS disorders and oncology [8] - The company has a strong clinical portfolio, including two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [8] - Oryzon's team consists of highly qualified professionals from the pharmaceutical industry, with operations in Barcelona, Boston, and San Diego [8] Clinical Trial Details - The PORTICO-2 trial will be a randomized, double-blind, placebo-controlled, multi-center study aiming to enroll 350 patients [4] - The primary endpoint will be measured using the STAXI-2 Trait Anger scale (patient-reported), while the Overt Aggression Scale-Modified (OAS-M) will serve as a key secondary endpoint [3][4] - The trial design was refined with input from leading psychiatric experts and developed through interactions with the FDA [2][4] Disease Context - BPD affects approximately 1-2% of the general population and is characterized by emotional instability, impulsivity, and frequent episodes of aggression [5] - There are currently no FDA-approved medications specifically indicated for the treatment of BPD, highlighting the urgent need for new therapeutic approaches [5] - More than 75% of BPD patients attempt suicide, with a completed suicide rate estimated at around 10%, significantly higher than the general population [5] Future Directions - Oryzon plans to explore vafidemstat's potential in managing aggression in other conditions, including Autism Spectrum Disorder (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD) [6] - A dedicated Key Opinion Leader (KOL) webinar is planned to discuss the PORTICO-2 study design and the unmet medical need in BPD [4]