ORYZON Announces Last Patient Last Visit in its Phase IIb PORTICO Study for Borderline Personality Disorder (BPD)

• Company on track to report top line data milestone in 1Q 2024
  
• A total of 210 participants have been recruited
• Multiple primary endpoints include reduction in agitation and aggression and overall BPD disease improvement
  

MADRID, Spain and BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with a strong unmet medical need, today announced Last Patient Last Visit in its ongoing Phase IIb PORTICO trial, investigating vafidemstat’s efficacy in Borderline Personality Disorder (BPD).

PORTICO (EudraCT No.: 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double-blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population. The trial has two primary endpoints: reduction of agitation and aggression and overall disease improvement in BPD severity. As independent multiple primary endpoints, statistical significance in either one is sufficient to declare success in the trial.

The trial has opened a total of 27 clinical sites, 14 in the U.S. and 13 in Europe (Germany, Spain, Bulgaria, and Serbia), and has recruited a total of 210 patients, randomized 1:1 in two arms. Last March, a pre-specified Interim Analysis qualified PORTICO as non-futile and recommended that the trial should continue as it is without increasing the number of patients to be recruited. The independent Data Monitoring Committee (DMC) has met routinely and reviewed unblinded safety data throughout the PORTICO trial. The last analysis corresponded to the initial 198 randomized patients (data cut-off, August 2023) and the DMC recommended continuing the trial without modifications until full enrollment (data recently presented at ECNP 2023). Current safety data of PORTICO are aligned with previous vafidemstat trials and continue to support that vafidemstat is safe and well-tolerated. Topline results are expected in Q1 2024, followed by a full data presentation at a psychiatric conference and in a peer-reviewed journal publication.