ORYZON Expands Vafidemstat Patent Portfolio with New Grant Decisions

Oryzon Genomics, S.A., a biopharmaceutical company specializing in epigenetics to develop treatments for diseases with significant unmet needs, has announced new patent approvals for its drug vafidemstat, an LSD1 inhibitor. The Australian Patent Office has granted a patent for the use of LSD1 inhibitors, including vafidemstat, to treat aggression and social withdrawal. This patent will be valid until at least 2038, with potential extensions. Similar approvals have been received in Malaysia, Europe, and Korea, with additional patents pending in other major markets.

Moreover, the Mexican Patent Office has granted a patent for Oryzon's method of treating borderline personality disorder (BPD) with vafidemstat, extending its validity until 2040. Japan has also granted similar protections, and additional patents are under review in other territories.

Neus Virgili, Chief IP Officer of Oryzon, expressed satisfaction with the expanding patent portfolio, emphasizing the enhanced commercial lifespan of vafidemstat in CNS disorders with substantial market potential, such as BPD. Dr. Carlos Buesa, CEO of Oryzon, echoed this sentiment, highlighting the strategic importance of these patents.

Oryzon Genomics, founded in 2000 in Barcelona, is a leading biopharmaceutical company in Europe focusing on personalized medicine for CNS disorders and oncology. The company's advanced clinical portfolio includes two LSD1 inhibitors: vafidemstat for CNS applications and iadademstat for oncology, both undergoing Phase II clinical trials. Additionally, Oryzon is developing other pipeline assets targeting epigenetic factors, such as HDAC-6, for potential use in conditions like Charcot-Marie-Tooth (CMT) disease and Amyotrophic Lateral Sclerosis (ALS).

Vafidemstat (ORY-2001) is an oral LSD1 inhibitor optimized for CNS conditions. It has shown promise in reducing cognitive impairment, neuroinflammation, and exhibiting neuroprotective effects. In animal models, vafidemstat has restored memory, reduced aggression, and improved sociability. The drug has also demonstrated efficacy in preclinical models of multiple sclerosis (MS). Oryzon has conducted Phase IIa clinical trials with vafidemstat in psychiatric disorders (REIMAGINE), moderate to severe Alzheimer's disease (REIMAGINE-AD), and MS (SATEEN), all yielding positive results. Additionally, vafidemstat was tested in severe COVID-19 patients (ESCAPE) and showed significant anti-inflammatory effects.

Oryzon is currently investigating vafidemstat in two Phase IIb trials: EVOLUTION, focused on schizophrenia, and PORTICO, targeting BPD. Following the positive results from PORTICO, the company has requested an End-of-Phase II meeting with the FDA to discuss potential Phase III trials for BPD. Furthermore, Oryzon is employing a precision medicine approach with vafidemstat in genetically-defined subpopulations of CNS disorders, preparing a trial for Kabuki Syndrome patients, and exploring other neurodevelopmental syndromes.

Oryzon continues to strengthen its intellectual property portfolio, enhancing the value proposition of its lead candidate, vafidemstat, in addressing major CNS disorders with high market potential.