ORYZON Receives Two Grants to Further Explore the Role of Epigenetic Targets in the Treatment of Neuronal Pathologies

  • Two collaborative projects with public research centers with a global budget of 2.3 million euros
  • Oryzon to receive up to 1.4 million euros
  • Focused on the discovery and validation of novel biomarkers and epigenetic targets for the treatment of neuronal pathologies

MADRID, Spain and BOSTON, Oct. 03, 2023 (GLOBE NEWSWIRE) — 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 the granting, through a provisional resolution proposal, of two aids within the Spanish research plan 2021-2023 for public-private collaboration projects: the DICTIONIS Project with a budget of 951,000 euros (€) and the MODERN Project with a budget of €1,328,594. The plan is funded by the Spanish State Research Agency and the Ministry of Science and Innovation within the framework of the recovery, transformation and resilience plan financed by the European Union (NextGenerationEU).

The DICTIONIS Project will be carried out in collaboration with the Fundació Centre de Regulació Genomica from Barcelona (Spain) and focuses on the diagnosis of chromatinopathies by detecting alterations in histone modifications.

The MODERN Project will be carried out in collaboration with the Universitat Autònoma de Barcelona, the Fundació de Institut d’Investigació Biomédica de Bellvitge (IDIBELL) and LEiTAT and focuses on high-throughput technologies for the discovery and validation of new epigenetic targets and inhibitors for the treatment of neuronal pathologies.

Both projects started on April 1, 2023 and will have a duration of two years. The projects have an overall budget of €2.3 million euros, of which Oryzon will receive approximately a €1.35 million aid and an additional grant to hire two Ph.D.s.

Dr. Jordi Xaus, Oryzon’s Chief Scientific Officer, said: “We thank the Spanish Ministry of Science for these aids that underline the scientific relevance of our research in the epigenetic area in neurological diseases, as well as to reinforce efficiencies and multiply efforts with the national network of public research institutions. These programs are a continuation and complement to our vafidemstat program, which is already in Phase 2 in two highly prevalent psychiatric diseases, borderline personality disorder and schizophrenia, and reinforce the company’s leadership in the development of innovative drugs against epigenetic targets useful in the treatment of neurological pathologies, a field of great medical need and with an important commercial opportunity.”

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.

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.

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