Oryzon Genomics, S.A. announced positive outcome from its planned, prespecified interim analysis of its Phase 2b trial, PORTICO, with vafidemstat for borderline personality disorder (BPD). These results were determined by an Independent Data Monitoring Committee (IDMC) that met on March 30, 2023. Based planned interim analysis of the first 90 participants who completed treatment, the trial was determined to be non-futile.

Based in the efficacy and safety data, the IDMC recommended to continue the trial without any modifications. PORTICO (EudraCT No.: 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a multicenter, double-blind, randomized, placebo-controlled, Phase IIb trial to evaluate the efficacy and safety of vafidemstat in adult BPD patients. The trial has two primary independent objectives: to reduce agitation and aggression and an overall improvement of BPD.

The trial is currently actively recruiting patients in Europe and in the US and aims to include about 188 patients distributed between two arms.