ORYZON Expands Vafidemstat Patent Portfolio

Oryzon Genomics, a leading biopharmaceutical company in Europe, has announced significant advancements in its intellectual property portfolio with new patent grants in Europe and Japan. The European Patent Office has issued a "Decision to grant" for Oryzon's application relating to vafidemstat, a potential treatment for Attention Deficit Hyperactivity Disorder (ADHD) using KDM1A inhibitors. This patent, once formalized, will extend protection until at least 2040, barring any extensions. Similarly, a corresponding patent in Japan, focusing on autism spectrum disorder treatment, has been granted and is expected to provide similar protection.

Vafidemstat, an LSD1 inhibitor, is being developed by Oryzon for various psychiatric conditions. The company's Chief IP Officer, Neus Virgili, expressed that these new patent approvals enhance Oryzon's global intellectual property standing, reinforcing the potential commercial viability of vafidemstat across central nervous system (CNS) disorders. These developments further bolster Oryzon's already substantial patent portfolio for vafidemstat, which includes protections for treating aggression, social withdrawal, and borderline personality disorder across multiple countries.

Oryzon Genomics, founded in 2000 and based in Barcelona, is recognized for its expertise in epigenetics and commitment to personalized medicine for CNS disorders and oncology. The company's clinical pipeline is robust, featuring two primary LSD1 inhibitors: vafidemstat, which is nearing Phase III trials for CNS applications, and iadademstat, currently in Phase II for oncology. Oryzon's research and technological infrastructure also support biomarker discovery and target validation for a range of neurological and malignant diseases.

Vafidemstat has shown promise in various preclinical and clinical settings, particularly for CNS-related disorders. It is designed to mitigate cognitive decline and neuroinflammation while offering neuroprotective benefits. In animal studies, vafidemstat has effectively restored memory and reduced aggression in aging and Alzheimer’s disease models while promoting social behavior in other murine models. In multiple sclerosis models, the compound demonstrated strong anti-inflammatory effects.

Clinical investigations have further highlighted the potential of vafidemstat. Phase II trials, such as REIMAGINE and REIMAGINE-AD, have demonstrated positive outcomes in managing aggression in psychiatric patients and Alzheimer's disease. Additionally, the ETHERAL trial indicated significant reductions in the inflammatory biomarker YKL40 among Alzheimer’s patients over treatment periods. The SATEEN trial for multiple sclerosis also reported promising anti-inflammatory results.

In the context of severe COVID-19, vafidemstat has been evaluated in the ESCAPE trial, where it showed significant anti-inflammatory effects, potentially preventing acute respiratory distress syndrome. Presently, vafidemstat is advancing towards Phase III trials for borderline personality disorder, following promising data from the PORTICO trial. Oryzon is planning further clinical evaluations, including a Phase III PORTICO-2 trial addressing agitation and aggression in this disorder.

Additionally, vafidemstat is being studied in a Phase IIb trial for negative symptoms of schizophrenia and is part of a broader precision medicine approach targeting genetically-defined CNS patient subpopulations. Future plans include exploring its potential in Kabuki Syndrome and other neurodevelopmental conditions.

Through these developments, Oryzon Genomics continues to strengthen its position as a leader in epigenetics and personalized medicine, driving forward innovative treatments for challenging CNS disorders.