Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a global leader in epigenetics, today announced that it has received a “Decision to grant” communication from the Japanese Patent Office for its patent application JP2023-136283, titled “Methods of treating behavior alterations”, related to vafidemstat, Oryzon’s LSD1 inhibitor in clinical development for the treatment of psychiatric disorders.
The allowed claims cover the use of vafidemstat for the treatment of aggression and social withdrawal – two symptoms associated with several CNS disorders. Oryzon is preparing a Phase III trial to evaluate vafidemstat for the treatment of aggression in borderline personality disorder (BPD). The Company is also preparing a Phase II trial in aggression in autism spectrum disorder (ASD) patients, and a Phase II trial is already ongoing in schizophrenia.
A “Decision to grant” is an official communication from a national patent office indicating that a patent application has met all requirements for issuance as a granted patent. Once formally granted, this Japanese patent will remain in force until at least 2038, excluding any potential patent term extension, which could provide additional years of protection. Corresponding patents have already been granted or allowed in Europe, Australia, Canada, Hong Kong, Israel, South Korea, Malaysia, the Philippines, and Russia, and additional applications are pending in other countries.
“This patent allowance in Japan further expands our global patent portfolio and strengthens Oryzon’s IP position for vafidemstat, protecting key therapeutic indications under clinical development and supporting its long-term commercial potential”, said Neus Virgili, Oryzon’s Chief IP Officer.
In addition to this patent family, Oryzon holds other patents covering the use of vafidemstat for the treatment of CNS disorders, including a patent family directed to the treatment of BPD or non-aggressive symptoms of BPD, with patents granted or allowed in Europe, Australia, Japan, Mexico, Russia, Singapore, and South Africa, and additional applications pending in other countries. These patents are expected to remain in force until at least 2040, excluding any potential patent term extensions.
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 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, 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. Following completion of the global, randomized, double blind Phase IIb PORTICO trial in Borderline Personality Disorder (BPD), with final data presented at ECNP-2024, vafidemstat is advancing as a Phase III-ready asset for agitation/aggression in BPD (PhIII in preparation). 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 preparing a clinical trial in aggression in autistic conditions like Phelan-McDermid syndrome
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