ORYZON announces journal publication of final Phase IIa REIMAGINE results with vafidemstat in Psychiatry and Clinical Neurosciences
The Phase IIa study REIMAGINE evaluated the safety and preliminary efficacy of vafidemstat in agitation/aggression in borderline personality disorder (BPD), attention-deficit/hyperactivity disorder (ADHD) and autistic spectrum disorder (ASD).
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the final results of the Phase IIa REIMAGINE study, which evaluated the safety and efficacy of vafidemstat on aggression in adult patients with borderline personality disorder (BPD), attention-deficit/hyperactivity disorder (ADHD), and autistic spectrum disorder (ASD), were published online in Psychiatry and Clinical Neurosciences. A summary of the final data from this study had been previously released at the 2020 European Psychiatry Association (EPA) annual meeting.
Dr. Jordi Xaus, Oryzon’s CSO, stated, “We are pleased to publish these results in this prestigious clinical psychiatry journal as part of Oryzon’s continuous efforts to expand the current knowledge on the relevance of epigenetics in psychiatry and neurodevelopmental disorders. This innovative study, one of the first basket trials in CNS, was the first to demonstrate that targeting LSD1 is a safe and entirely novel mechanism of action for managing agitation/aggression in psychiatric disorders.”
Dr. Carlos Buesa, Oryzon’s CEO said “Vafidemstat is a promising molecule for managing agitation and aggression in various CNS disorders, as demonstrated in this Phase IIa trial. We are excited to design a Phase III trial in BPD, with guidance from leading U.S. psychiatrists, to evaluate its impact on this highly impairing feature of the disease. Successfully mitigating agitation and aggression could significantly improve BPD patients' daily lives. If the upcoming Phase III trial yields positive results, vafidemstat could be further explored for broader applications in controlling aggression across other CNS disorders.”
REIMAGINE was a Phase IIa, single-center, open-label, one-arm basket trial that evaluated the safety and efficacy of vafidemstat, Oryzon’s brain-penetrant, orally available LSD1 inhibitor, on aggression in adult patients with BPD, ADHD, and ASD. In the trial, participants received 1.2 mg/day of vafidemstat for 8 weeks. As reported in the publication, the study showed that vafidemstat was safe and well-tolerated and elicited significant and consistent reduction in agitation/aggression in patients with BPD, ADHD, and ASD. Vafidemstat also produced a significant improvement in nonaggressive features and overall disease indicators in these populations.
Based on the results from the REIMAGINE study, Oryzon continued the development of vafidemstat in psychiatric indications and conducted the Phase IIb PORTICO trial in BPD. In this trial, vafidemstat demonstrated nominal statistical significance in reducing agitation and aggression on the STAXI-2 Trait Anger scale and in improving overall BPD disease on the BEST scale, and also reached statistical significance on the Global Statistic Test. Following positive feedback from the End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA), Oryzon initiated preparations for Phase III and is currently preparing the full protocol for the PORTICO-2 Phase III trial for submission to the FDA. Vafidemstat is also being evaluated in the Phase IIb EVOLUTION trial in negative symptoms of schizophrenia.