ORYZON continues to strengthen its patent portfolio for vafidemstat

Oryzon Genomics, S.A., a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the Russian Patent Office has issued a “Decision to grant” communication for Oryzon’s Russian patent application RU2021130172, titled “Methods of treating borderline personality disorder”. This patent relates to vafidemstat, Oryzon’s LSD1 inhibitor in clinical development for the treatment of psychiatric disorders, including borderline personality disorder (BPD) and schizophrenia.

The “Decision to grant” is a formal communication from the Russian Patent Office indicating that the patent application has reached the stage where it is allowed for issuance as a patent. Once granted, this Russian patent will not expire until at least 2040, excluding any potential patent term extension, which could provide additional years of protection. Oryzon has also received “Decision to grant” communications for corresponding patent applications in Europe and Mexico, and a patent has already been granted in Japan. Patent applications are also pending in other relevant markets.

Additionally, Oryzon recently secured granted patents in Europe, Australia, Korea, Malaysia, and Russia under another patent family that covers the use of vafidemstat for the treatment of aggression and social withdrawal. Patent applications in additional countries are pending. These patents will not expire until at least 2038, excluding any potential patent term extensions.

“We are pleased with the continued progress of our global patent strategy for vafidemstat,” said Neus Virgili, Oryzon’s Chief IP Officer. “The issuance of these patents, including the recent “Decision to grant” in Russia, strengthens vafidemstat’s patent portfolio and will significantly extend its commercial lifespan.”

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 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) 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. Vafidemstat is being investigated in neuropsychiatric disorders in two double-blind, randomized, placebo-controlled Phase IIb trials: one in negative symptoms of schizophrenia, named EVOLUTION (recruitment ongoing), and another one in Borderline Personality disorder (BPD), named PORTICO, completed and with published final data. Following receipt of the minutes from the End-of-Phase II meeting with the FDA to discuss PORTICO’s results, the company recently announced plans to move forward with a Phase III PORTICO-2 trial in BPD. 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.