Home > Psychiatry > ECNP 2021 > Personality Disorders > Evaluating vafidemstat for the treatment of borderline personality disorder

Evaluating vafidemstat for the treatment of borderline personality disorder

Presented by
Ms Sonia Gutiérrez , Oryzon, Spain
Conference
ECNP 2021
Trial
Phase 2, PORTICO
Clinical trials on borderline personality disorder (BPD) face many methodological challenges, and none have resulted in an approved pharmacological treatment thus far. This may change with the ongoing phase 2b PORTICO trial aiming to evaluate the efficacy and safety of vafidemstat in an adult BPD population. A poster at ECNP 2021 explained the methodology and design of PORTICO [1].

So far, 17 clinical trials on BPD have failed. Methodological challenges include the lack of a ‘gold standard’ measure, uncertain but high placebo rate, large sample sizes, difficult and non-adherent patient population, endpoint timing challenges, and large percentages of BPD patients receiving psychotherapy [2]. PORTICO is the first real-world clinical trial designed to overcome many of these methodological challenges. It is designed as a double-blind, randomised, placebo-controlled, adaptive, 14-week phase 2b trial to evaluate the efficacy and safety of vafidemstat in adult BPD patients.

Vafidemstat is a selective inhibitor of the epigenetic target LSD1, modulating aggression and sociability. It represents a novel epigenetic approach for the treatment of BPD. It is this novel approach that is supposed to facilitate enrollment of a real-world BPD population, allowing common comorbidities, psychotherapy, and concomitant medications that would normally be exclusion criteria. It may also aid treatment adherence, decrease dropout rate, and result in cleaner data.

A maximum of 156 participants will be randomised 1:1 to 1.2 mg vafidemstat or placebo. About 124 of them are expected to complete the study, as about 20% of patients are projected to drop out of the trial. PORTICO will involve 9 study visits and a blinded protocol to reduce the risk of bias in the assessment of the study endpoints. The primary objectives of the trial are a reduction of aggression and agitation plus an overall improvement of BPD. Primary endpoints include the Clinician’s Global Impression-Severity focused on agitation and aggression (CGI-S A/A), and the Borderline Personality Disorder Checklist (BPDCL).


    1. Gutiérrez S, et al. PORTICO – Phase IIb trial evaluating vafidemstat, an epigenetic therapeutic approach, for the treatment of Borderline Personality Disorder. P.1004, ECNP 2021 Congress, 2–5 October.
    2. Ropacki MT. ISCTM Autumn Conference 2020, 21–25 September.

 

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