ORYZON to Host Virtual KOL Event on July 9, 2025

MADRID and CAMBRIDGE, Mass., June 25, 2025 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, announced today that it will host a virtual KOL event on Wednesday, July 9, 2025 at 12:00 pm ET. The event, moderated by Michael Ropacki, PhD and Oryzon’s CMO for CNS, will feature insights from leading experts:

• Alan F. Schatzberg, MD, MS(Hon) - Stanford University School of Medicine
• Emil F. Coccaro, MD - The Ohio State University College of Medicine
• Eric Hollander, MD - Albert Einstein College of Medicine
• Sarah Fineberg, MD, PhD - Yale University School of Medicine

The event will provide an overview of the current social and clinical challenges for patients with Borderline Personality Disorder (BPD). It will highlight the absence of approved pharmacological treatments, the limitations of off-label medications, and the critical role of agitation and aggression in BPD and other psychiatric conditions. The discussion will also explore the potential of emerging therapies, with a focus on vafidemstat. The panel will also briefly review Oryzon’s recent interactions with the FDA and the design of vafidemstat’s PORTICO-2 Phase III trial protocol, which was recently submitted, and how vafidemstat‘s novel epigenetic mechanism of action may represent a promising treatment approach for BPD, schizophrenia, and autism spectrum disorder (ASD).

A live Q&A session will follow the panel discussion.

To attend the event, please register in advance . For those who are unable to attend live, a replay will be available after the event.

KOL Biographies

Alan F. Schatzberg, MD, MS(Hon) is one of the most renowned American psychiatrists. Since 1991, he has been the Kenneth T. Norris Jr. Professor of Psychiatry and Behavioral Sciences at Stanford University School of Medicine. He was Chair of the Department of Psychiatry and Behavioral Sciences at Stanford from 1991 to 2010. He is also the co-editor-in-chief of the Journal of Psychiatric Research. Alan Schatzberg, as the APA president in 2009–10, was identified as the principal investigator on a federal study into the drug mifepristone for use as an antidepressant being developed by Corcept Therapeutics, a company Schatzberg had created and in which he had several million dollars' equity.

Emil F. Coccaro, MD is currently the George T. Harding, MD, III Endowed Professor of Psychiatry at The Ohio State University in its College of Medicine. He received his MD from the New York University School of Medicine and his training in Psychiatry from the Mt. Sinai Medical Center in New York City. Dr Coccaro had academic appointments at the Mt. Sinai School of Medicine (1983-1989), the Medical College of Pennsylvania/Hanemann College of Medicine (1989-1999), and The University of Chicago (1999-2021), where he was also the Chair of Psychiatry & Behavioral Neuroscience (2004-2016). He is a leading expert in the neurobiology of aggression and impulsivity. His seminal contributions to the field include studies into the roles of serotonin (as well as the role of chronic inflammation) in impulsive aggression. In addition, he developed the methodology to test the efficacy of anti-aggressive compounds in clinical trials starting with his positive clinical trial of fluoxetine in impulsive aggressive individuals. He also developed the DSM-5 criteria for Intermittent Explosive Disorder (IED) as well as several rating measures currently used in human studies of aggression, including the Life History of Aggression (LHA) and the Overt Aggression Scale Modified for Outpatient Use (OAS-M), among others.

Eric Hollander, MD is a Professor of Psychiatry and Behavioral Sciences at the Albert Einstein College of Medicine and Director of the Autism and Obsessive Compulsive Spectrum Program, and the Anxiety and Depression Program, at Montefiore Medical Center and the Albert Einstein College of Medicine. Previously he served as the Esther and Joseph Klingenstein Professor and Chair of Psychiatry at the Mount Sinai School of Medicine and was Director of the Seaver and NY Autism Center of Excellence in New York City. Before then he served as Associate Professor of Clinical Psychiatry at the Columbia University College of Physicians and Surgeons in New York. His main areas of research are CBDV in Autism Spectrum Disorder (ASD); Oxytocin in Prader Willi Syndrome (PWS); Vasopressin 1a antagonists in ASD; and novel treatments for Intermittent Explosive Disorder, Borderline Personality Disorder and Obsessive Compulsive and Related Disorders, including Body Dysmorphic Disorder, Pathological Gambling, and Problematic Use of the Internet.

Sarah Fineberg, MD, PhD is Assistant Professor of Psychiatry at Yale University investigating the neurobiological mechanisms behind borderline personality disorder (BPD) and related mental health conditions. She is also interested in testing the efficacy of novel and emerging treatments. She has participated in several BPD studies. Dr. Fineberg holds an MD PhD from the University of Iowa, where she studied the molecular mechanisms that control early fate decisions for neural stem cells in mouse brain. She came to Yale in 2010 to pursue clinical and research training in psychiatry. Her current research engages both stories and brain-based mechanisms of mental illness, asking questions about how patient social experiences relate to neural circuits and learning mechanisms. Dr. Fineberg has been awarded young investigator grants from the Brain and Behavior Research Foundation and the American Foundation for Suicide Prevention to pursue studies about social learning in Borderline Personality Disorder.

About Oryzon

Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS (Phase III-ready) and iadademstat in oncology (Phase II). The company has other pipeline assets directed against other epigenetic targets like HDAC-6 where a clinical candidate, ORY-4001, has been nominated for its possible development in CMT and ALS. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit

About Vafidemstat

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. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong, and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed two Phase IIa clinical trials in aggressiveness in patients with different psychiatric disorders (REIMAGINE, see Ferrer et al, Psychiatry & Clin Neurosci, 2025, doi.org/10.1111/pcn.13800) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive clinical results reported in both. Additional finalized Phase IIa clinical trials with vafidemstat include the ETHERAL trial in patients with Mild to Moderate AD, where a significant reduction of the inflammatory biomarker YKL40 was observed after 6 and 12 months of treatment, and the pilot, small-scale SATEEN trial in Relapse-Remitting and Secondary Progressive MS, where anti-inflammatory activity was also observed. Vafidemstat has also been tested in a Phase II in severe Covid-19 patients (ESCAPE) assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Vafidemstat is currently advancing as a Phase III-ready asset in Borderline Personality disorder (BPD) following completion of the global, randomized, double blind Phase IIb PORTICO trial (final data presented at ECNP-2024). Following receipt of the minutes from the End-of-Phase II meeting with the FDA to discuss PORTICO’s results, the company announced plans to move forward with a Phase III PORTICO-2 trial in agitation/aggression in BPD (PhIII protocol submitted to FDA). Vafidemstat is also being investigated in a double-blind, randomized, placebo-controlled Phase IIb trial in negative symptoms of schizophrenia (EVOLUTION trial, recruitment ongoing). The company is also deploying a CNS precision medicine approach with vafidemstat in genetically defined patient subpopulations of certain CNS disorders, as well as in neurodevelopmental syndromes, and is evaluating the feasibility of conducting clinical trials in autistic conditions like Fragile X syndrome and Phelan-McDermid syndrome.

FORWARD-LOOKING STATEMENTS  

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