Oryzon Genomics, S.A. announced that it has received approval from the Serbian Medicines and Medical Devices Agency (ALIM) for its Clinical Trial Application (IND equivalent) to conduct a Phase IIb clinical trial with vafidemstat in patients with Borderline Personality Disorder (BPD) in Serbia. The trial is already active and recruiting patients in Spain, Bulgaria, Germany and the USA. PORTICO (EudraCT No.: 2020-003469-20, ClinicalTrials.gov [1] 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 will be conducted in 15-20 sites in Europe and US and aims to include about 160 patients distributed between two arms. PORTICO 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.