ORYZON announces approval for Serbian arm of PORTICO, vafidemstat’s Phase IIb trial in Borderline Personality Disorder

Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today 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 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..

Oryzon’s Chief Medical Officer for CNS, Dr. Michael Ropacki, said: “The launch in Serbia concludes the deployment phase of PORTICO and will contribute to accelerate its execution. The PORTICO’s protocol pre-specifies an interim analysis after the first 90 participants have completed the trial. It is anticipated that this should occur before the end of 2022. Considering the role of epigenetics in psychiatric illness, and in BPD in particular, as well as the previous positive data from the REIMAGINE trial in BPD patients, Oryzon believes that vafidemstat could be transformative in the treatment and lives of BPD patients”.

PORTICO’s scientific rationale is based on vafidemstat’s ability to inhibit LSD1, reducing aggression, enhancing sociability and mitigating social withdrawal, as demonstrated in several preclinical models (see Maes et al., PLOS ONE 2020 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0233468). PORTICO builds on the Phase IIa REIMAGINE trial, where vafidemstat reduced agitation-aggression in patients with BPD, attention deficit hyperactivity disorder and autism spectrum disorder and showed positive global effects across these psychiatric disorders, particularly BPD, after 2 months of treatment. Vafidemstat has shown a favorable safety and tolerability profile in multiple Phase I/II clinical trials, with over 300 subjects treated, some for up to 24 months. Importantly, vafidemstat has not been associated with sedation, weight gain or extrapyramidal side effects, which are common in current antipsychotic therapy, nor with any other adverse events. 

 

Mire information and contact in the file attached.