ORYZON receives 'Decision to grant' for two important patents for vafidemstat in Japan

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 that it has received “Decision to grant” communications from the Japanese Patent Office (JPO) for two Japanese patent applications related to vafidemstat, Oryzon’s LSD1 inhibitor in clinical development for the treatment of psychiatric disorders like BPD and schizophrenia. These two patent applications are JP2021-556616 entitled “Methods of treating borderline personality disorder” and JP2021-556629 entitled “Methods of treating attention-deficit hyperactivity disorder using KDM1A inhibitors such as the compound vafidemstat”. The allowed claims cover the use of vafidemstat for the treatment of BPD and ADHD, respectively.

The Decision to grant is a formal communication from the JPO in which it indicates that a patent application has reached the status where it is allowed for issuance as a patent. Both patents, once granted, will not expire until at least 2040, excluding any potential patent term extensions that may provide additional protection. Corresponding patent applications are pending in several additional major pharmaceutical markets.

Oryzon had recently received Decision to grant communications from the European and Korean patent offices for additional important patents for vafidemstat, covering its use for the treatment of aggression and social withdrawal. A corresponding patent has already been granted in Russia.

“We are delighted to have obtained allowance for these two Japanese patent applications, which further strengthen the multiple layers of protection we have built around vafidemstat”, said Neus Virgili, Oryzon’s Chief IP Officer.

“Our growing intellectual property portfolio reinforces the unique value proposition for vafidemstat, extending substantially its commercial life in CNS indications with large market potential like BPD or ADHD”, stated Dr. Carlos Buesa, Chief Executive Officer of Oryzon.

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 schizophrenia, named EVOLUTION (recruitment ongoing), and another one in Borderline Personality disorder (BPD), named PORTICO, finalized and with published topline data. Based on PORTICO’s results, the company has requested an End-of-Phase II meeting with the FDA to discuss options for a registrational Phase III 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.