A patient In Vall d’Hebron University Hospital has been the first one to be enrolled in the PORTICO study worldwide. It is a Phase IIb clinical trial with vafidemstat in Borderline Personality Disorder (BPD) patients led by Oryzon Genomics S.A.
PORTICO is a multicenter, double-blind, randomized, placebo-controlled Phase IIb trial to evaluate the efficacy and safety of vafidemstat in BPD patients. The two primary independent objectives of the trial will be a reduction of aggression and agitation and an overall improvement of BPD.
The study will include 156 patients in total, with 78 patients in each arm, and as an adaptive design has a pre-defined interim analysis to adjust the sample size in case of excessive variability around the endpoints or an unexpectedly high placebo rate. The study has started in Europe with the activation of two sites, Vall d’Hebron Hospital and Santa Creu i Sant Pau Hospital. It is expected that around 20 sites from Spain, Germany, Bulgaria and Serbia as well as the United States will participate in the study. Recruitment is expected to complete in approximately 18 months.
Oryzon’s Chief Medical Officer for CNS, Dr. Michael Ropacki, said “PORTICO is the first interventional clinical trial in a real-world BPD population, with inclusion and exclusion criteria designed to offer the highest potential for a viable treatment option for BPD patients. These patients are typically treated off-label with drugs with significant side-effect profiles”. Vafidemstat has already proven to be safe and well-tolerated in clinical trials in approximately 300 treated subjects, some on continuous therapy for up to 18 months. Vafidemstat is non-sedating, does not cause unwanted weight gain or produce extrapyramidal side effects.
Vafidemstat (ORY-2001) is an oral, CNS optimized LSD1 inhibitor. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects.
About Borderline Personality Disorder
Borderline Personality Disorder (BPD) is one of the most complex, functionally debilitating and costly psychiatric illnesses for health care systems, affecting between 0.5 and 1.6% of the general population. BPD patients often experience emotional instability, impulsivity, irrational beliefs and distorted perception, and intense but unstable relationships with others. Up to 10% of those affected die by suicide. Psychotherapy is the first-line treatment and while medications may be prescribed to treat specific symptoms, there is no FDA-approved treatment for BPD patients. It is estimated that around 1.4 million BPD patients in the U.S. are being treated with off-label drugs, approved for other conditions and which manage symptoms rather than the disease itself.