Oryzon Genomics has reported positive preliminary blinded aggregate safety data from its Phase IIb PORTICO trial of vafidemstat for the treatment of Borderline Personality Disorder (BDP).
The ongoing, placebo-controlled, randomised, double-blind, multicentre study has been designed to assess the safety and efficacy of vafidemstat in adult BPD patients.
Reducing agitation and aggression, as well as producing an overall improvement in BPD severity, are the two primary independent objectives of the study.
The initial 167 patients were reviewed by independent DMC members and the data showed no deaths or treatment-related serious adverse events.
Despite this, 98 patients treated either with vafidemstat or a placebo reported 306 adverse events, with 216 mild and 78 moderate symptoms.
The remaining 12 symptoms were severe in nine patients, leading to withdrawals, while six patients discontinued the treatment.
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Unblinded safety data was also reviewed following the blinded portion of the DMC. Members of the DMC recommended that the trial continue without modifications until full enrolment.
The study intends to enrol a total of 188 patients from Europe and the US early in the third quarter of this year.
In case of excessive variations observed around the endpoints, PORTICO’s adaptive design with a pre-defined interim analysis (IA) can adjust the sample.
This March, a predefined independent IA carried out on the first 90 patients showed that PORTICO was not futile and should continue as it is, without the enrolment of more patients.
In March last year, Oryzon announced a Phase Ib clinical trial of iadademstat for the treatment of acute myeloid leukaemia harbouring an FMS-like tyrosine kinase mutation (FLT3mut+).
The study enrolled nearly 45 subjects from ten to 15 study centres in the US.