Oryzon Genomics, S.A. announced the enrollment of the first patient in the US in its Phase IIb clinical trial with vafidemstat, a selective inhibitor of the epigenetic target LSD1, in Borderline Personality Disorder (BPD) patients. PORTICO is a multicenter, double-blind, randomized, placebo-controlled Phase IIb trial to evaluate the efficacy and safety of vafidemstat in BPD patients. The two primary independent objectives of the trial are a reduction of aggression and agitation and an overall improvement of BPD. The study aims to include 156 patients in total, with 78 patients in each arm, and has an adaptive design with a pre-defined interim analysis to adjust the sample size in case of excessive variability around the endpoints or an unexpectedly high placebo rate. The study is already approved in Europe by the Spanish, German and Bulgarian Medicine Agencies. PORTICO builds on clinical data from the Phase IIa REIMAGINE trial, where vafidemstat reduced agitation-aggression in patients with attention deficit and hyperactivity disorder (ADHD), autism spectrum disorder (ASD) and BPD after 2 months of treatment, and from the Phase IIa REIMAGINE-AD trial, where vafidemstat reduced agitation-aggression in patients with severe and moderate Alzheimer's disease after 6 months of treatment. Vafidemstat has proven to be safe and well-tolerated across multiple clinical trials in more than 300 treated subjects, some on continuous therapy for up to 24 months. PORTICO’s scientific rationale is based on vafidemstat’ s ability to inhibit selectively LSD1 and modulate aggression and sociability, as tested in several preclinical models.