ORYZON to Host KOL Event on Phase IIb PORTICO Topline Study Results of Vafidemstat in Borderline Personality Disorder on January 25, 2024

ORYZON to Host KOL Event on Phase IIb PORTICO Topline Study Results of Vafidemstat in Borderline Personality Disorder on January 25, 2024




ORYZON to Host KOL Event on Phase IIb PORTICO Topline Study Results of Vafidemstat in Borderline Personality Disorder on January 25, 2024

MADRID, Spain and BOSTON, Jan. 19, 2024 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with a strong unmet medical need, today announced that it will host a virtual KOL event on Thursday, January 25, 2024 at 10:00 am ET to briefly review, then discuss the topline results from the Phase IIb PORTICO study evaluating vafidemstat in Borderline Personality Disorder (BPD). To register for the event, click here.

The event will feature a brief review of the topline results of the Phase IIb PORTICO study, then a discussion with:

KOL Dyanna Domilici, MD (Adams Clinical, Copley Clinical), PORTICO U.S. PI and Psychiatrist.  

KOL Marc Ferrer, MD, PhD (Vall d’Hebron University Hospital), PORTICO E.U. PI and Psychiatrist.

KOL Sarah Fineberg, MD, PhD (Yale School of Medicine), a Psychiatrist not involved with PORTICO to provide an independent clinician’s perspective on the potential clinical and real-world implications for the results.

A live question and answer session will follow the formal presentations. A replay of the webcast will be available on the company’s website after the event.

About Dyanna Domilici, MD
Dr. Dyanna Domilici is a psychiatrist by training and currently works as a Principal Investigator at Adams Clinical and Copley Clinical, two outpatient clinical research sites in the Greater Boston area that specialize in neurologic and psychiatric drug development. In addition to providing clinical trial oversight, she performs psychological and neurological rating scales for trials in Borderline Personality Disorder, Major Depressive Disorder, Social Anxiety Disorder and Alzheimer’s Disease. Prior to joining Adams Clinical in 2018, Dr. Domilici served as Medical Director for the Inpatient Psychiatric Unit at Beth Israel Deaconess Medical Center in Boston, MA before moving on to start the Psychiatric Consultation Liaison Service at Mass General Brigham’s Newton-Wellesley Hospital in Newton, MA, where she later served as the Associate Chair of Psychiatry from 2014-2017. After completing undergraduate and graduate studies at Johns Hopkins University, she received her MD from the University of South Carolina School of Medicine and is a 2005 graduate of the Harvard Longwood Psychiatric Residency Training Program. Dr. Dyanna Domilici was a Principal Investigator in the PORTICO trial.

Sarah Fineberg, MD, PhD
Dr. Sarah 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 initially became interested in science as an undergraduate student at Oberlin College in physiology classes, where mechanism came alive in narratives about the evolutionary and individual history of the organism. She moved to Yale School of Medicine in 2010 to pursue clinical and research training in psychiatry. As an Assistant Professor of Psychiatry at Yale, 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 is considered an expert in Borderline Personality Disorder and 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 Marc Ferrer, MD, PhD
Dr. Marc Ferrer currently serves as the Coordinator of the Comprehensive Care Program for Borderline Personality Disorder (BPD) at Vall d’Hebron University Hospital in Barcelona (Spain). With a PhD in Psychiatry and Clinical Psychology and a degree in Medicine and Surgery from the Autonomous University of Barcelona (UAB), he is a recognized Specialist in Psychiatry through MIR at Hospital de la Santa Creu i Sant Pau. Dr. Ferrer is also an Associate Psychiatrist at Vall d’Hebron University Hospital and is involved as a Psychiatrist at the Galatea Clinic, contributing to programs such as PAIME, Retorn, and Itaca. Additionally, Dr. Ferrer is an Associate Professor in the Psychiatry and Legal Medicine Department at UAB. He treats patients with and conducts research in BPD, ADHD, and Dual Pathology and has specific training in Dialectical Behavioral Therapy (DBT) from Behavioral Tech LLC. Dr. Ferrer was a Principal Investigator in the PORTICO trial.

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 and iadademstat in oncology, in several Phase II clinical trials. The company has other pipeline assets directed against other epigenetic targets. 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 www.oryzon.com

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) 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 has been 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 has also been 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. Currently, vafidemstat is in two Phase IIb trials in borderline personality disorder (PORTICO) and in schizophrenia patients (EVOLUTION). The company is also deploying a CNS precision medicine approach with vafidemstat in genetically-defined patient subpopulations of certain CNS disorders and is preparing a clinical trial in Kabuki Syndrome patients. The company is also exploring the clinical development of vafidemstat in other neurodevelopmental syndromes.

About Borderline Personality Disorder
Borderline Personality Disorder (BPD) is one of the most complex, functionally debilitating and costly psychiatric illnesses for healthcare 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.

FORWARD-LOOKING STATEMENTS
This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events, or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzon’s securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon’s securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.

IR, US IR & Media, Europe Spain Oryzon
Ashley R. Robinson Sandya von der Weid Patricia Cobo/Daniel Foley Emili Torrell
LifeSci Advisors, LLC LifeSci Advisors, LLC Atrevia Chief Business Officer
+1 617 430 7577 +41 78 680 05 38 +34 91 564 07 25
+34 672 447 094
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arr@lifesciadvisors.com svonderweid@lifesciadvisors.com pcobo@atrevia.com
dfoley@atrevia.com
etorrell@oryzon.com