ORYZON announces Last Patient Last Visit in its Phase IIb PORTICO study for Borderline Personality Disorder (BPD)
Multiple primary endpoints include reduction in agitation and aggression and overall BPD disease improvement.
Oryzon Genomics, S.A., 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 doubleblind, 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. Asindependent 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 prespecified 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.
“We are pleased to have completed the follow-up of all patients in our Phase IIb PORTICO trial, bringing us one step closer to reporting topline data from the study, which we anticipate in 1Q2024", said Dr. Carlos Buesa, CEO of Oryzon. "We have ambitiously designed PORTICO to investigate, independently, improvements in the overall severity of the disease and in the agitation-aggression levels. Our quest on the primary endpoints is replicated in a rich set of secondary endpoints, making PORTICO a very informative trial. If any of these data are positive, PORTICO will represent a significant step forward in bringing a first specific therapeutic option to these needed patients.”
“We want to thank all the participants with BPD, and for the collaboration of the investigators and their staff as well as the clinical team who all helped get us to achieve the important milestone of last patient last visit in PORTICO. The team focus will remain on data cleaning, database lock, and topline results anticipated in Q1 2024. We hope that the PORTICO efficacy data will align with the safety supporting vafidemstat as an extremely safe and well-tolerated potential therapy for BPD, a condition with no currently approved drug treatments”, said Dr. Michael Ropacki, Chief Medical Officer for CNS at Oryzon.