ORYZON initiates a new project to explore the efficacy of vafidemstat in the treatment of schizophrenia
- Will receive € 0.7 million public funding from the Spanish Ministry of Science and Innovation
- In collaboration with the Research Institute of the Hospital de la Vall d’Hebrón in Barcelona (VHIR)
MADRID, SPAIN and CAMBRIDGE, USA, June 15th, 2020 - 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 its project entitled “VENCER: Vafidemstat: Efficacy in the treatment against Schizophrenia and other related pathologies” has been approved for funding by the Spanish Ministry of Science and Innovation under the 2019 call of the governmental R&D “RETOS-COLABORACION” program. The company will carry out this project in Collaboration with the Group of Psychiatry, Mental Health and Addictions of the Research Institute of Vall d’Hebrón (VHIR) in Barcelona. The project has an initial global budget of € 1,129,716.
This new public funding, structured in the form of a preferential long-term soft-loan for companies and non-reimbursable grants for the participating Public Research Organizations, comprises a loan to Oryzon for €688,517 plus a grant of €332,601 to the VHIR. The project will explore the efficacy of vafidemstat, a Phase II drug in development in central nervous system (CNS) disorders, in the treatment of patients with schizophrenia or related psychiatric disorders. This funding will partially cover the activities of the project, including activities related to a Phase II clinical study in schizophrenia patients and a set of additional research to gain further insight into the activity of vafidemstat in these psychiatric patients. The project is foreseen to last a maximum of 39 months, with a start scheduled for next October 1, 2020.
The Group of Psychiatry, Mental Health and Addictions of the Research Institute of Vall d’Hebrón (VHIR) led by Dr Ramos-Quiroga and Oryzon have already successfully collaborated on a recent Phase IIa clinical trial called REIMAGINE, where vafidemstat was shown to reduce agitation and aggression in psychiatric patients with borderline personality disorder, autism, and attention deficity hyperactivity disorder (ADHD), as well as to improve their general clinical condition. In addition to the interest that vafidemstat’s mechanism of action has for general population with schizophrenia, independent research results recently published by U.S. universities show that some genetic mutations involved in the evolution of schizophrenia can be mitigated by Oryzon’s LSD1 inhibitors.
Roger Bullock, Chief Medical Officer of Oryzon, commented: "This new study in schizophrenia patients will continue the efforts made in the last three years to demonstrate the ability of vafidemstat to exert a positive effect in the treatment of disorders of the behavior in a wide range of neurodegenerative and psychiatric indications and we hope that in the future it will provide positive results in these patients such as those already presented in the REIMAGINE and REIMAGINE-AD trials in patients with borderline personality disorder, autism spectrum disorder or attention deficit hyperactivity disorder and in patients with Alzheimer's disease.”
Dr. Ramos-Quiroga, Head of the Group of Psychiatry, Mental Health and Addictions of the Research Institute of Vall d’Hebrón (VHIR) said, “The epigenetic modulation exerted by vafidemstat has opened up a new paradigm in the search for safer and more efficacious treatments for mental disorders where neurodevelopment dysfunctions co-exist with environmental triggers.”
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. Oryzon has one of the strongest portfolios in the field. Oryzon’s LSD1 program has rendered two compounds, vafidemstat and iadademstat, in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurological diseases. Oryzon has offices in Spain and the United States. For more information, visit www.oryzon.com
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 a Phase IIa clinical trial in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive preliminary clinical results reported. Additional Phase IIa clinical trials with vafidemstat are ongoing in patients with Mild to Moderate AD (ETHERAL), where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 months of treatment, and in Relapse-Remitting and Secondary Progressive MS (SATEEN).
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