Oryzon announces completed patient recruitment in the PORTICO Phase IIb trial of vafidemstat in Borderline Personality Disorder
Multiple primary endpoints include reduction in agitation and aggression and overall disease improvement. Recent predefined Interim Analysis qualified PORTICO as non-futile.
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 reports that full patient recruitment has been completed in its ongoing Phase IIb PORTICO trial, investigating vafidemstat 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 multiple primary endpoints: reduction of agitation and aggression and overall disease improvement in BPD severity. The trial recruited patients in the US, Germany, Spain, Bulgaria and Serbia, and aims to analyze 150 patients who complete the trial, randomized in two arms at a 1:1 ratio.
The last patient out is expected before the end of 2023. Topline results are expected in Q1 2024, followed by a full data presentation at a psychiatric conference, as well as in a peer-reviewed journal publication.
“We are entering a very exciting period for Oryzon as we are approaching topline readout from the first randomized Phase IIb clinical trial investigating vafidemstat” said Dr. Carlos Buesa, Chief Executive Officer at Oryzon. “If positive, these results have the potential to be transformative for the treatment of BPD patients with a severe unmet need, and for Oryzon on our mission to support these patients”.
Dr. Michael Ropacki, Chief Medical Officer for CNS at Oryzon stated, “PORTICO is the first and largest real world randomized, double-blind, adaptive clinical trial in BPD. We are extremely excited by the interest and enrollment in PORTICO, want to thank all the collaboration of our investigator sites and their personnel and, most importantly, are extremely grateful for the contribution and dedication of the BPD patients who made PORTICO possible.”
The independent Data Monitoring Committee (DMC) met routinely and reviewed the safety data throughout the PORTICO trial. The last analysis corresponded to the initial 167 randomized patients (data cut-off, 23 May 2023) and the DMC recommended continuing the trial without modifications until full enrollment. Current safety data of PORTICO are aligned with previous vafidemstat trials and continue to support that vafidemstat is safe and well-tolerated. PORTICO has an adaptive design with a pre-defined interim analysis (IA) to assess the signal size and futility. This predefined IA was done with the data of the first 90 patients that had concluded at least two-thirds of the trial. The outcome of this IA was that PORTICO was not futile and should continue as it is without increasing the number of patients to be recruited.