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 additional “Decision to grant” communications for important patents relating vafidemstat, Oryzon’s LSD1 inhibitor in clinical development for the treatment of psychiatric disorders like borderline personality disorder (BPD) and schizophrenia.
The Australian Patent Office has issued a Decision to grant communication for Oryzon’s patent application AU2018309372 entitled “Methods of treating behavior alterations”. The allowed claims cover the use of LSD1 inhibitors, including vafidemstat, for the treatment of aggression and social withdrawal. This patent, once granted, will not expire until at least 2038, excluding any potential patent term extensions that may provide additional protection. A decision to grant has also been received in Malaysia. These two new decisions to grant add to the recent decisions to grant in the corresponding patent applications in Europe and Korea. A patent has already been granted in Russia, and patent applications are pending in other relevant markets.
In addition, a Decision to grant communication has been issued by the Mexican Patent Office for Oryzon’s patent application MX/a/2021/011256 entitled “Methods of treating borderline personality disorder”. This patent, once granted, will not expire until at least 2040. A decision to grant has already been received in the corresponding Japanese patent application, and patent applications are pending in other relevant markets.
“It is gratifying to see how we continue to build a stronger patent portfolio for vafidemstat with these new decisions to grant in these two important patent families. We remain confident that favourable outcomes will follow in additional countries”, said Neus Virgili, Chief IP Officer of Oryzon. “Our expanding IP portfolio strengthens the distinct value proposition of vafidemstat, significantly prolonging its commercial lifespan in CNS indications with a large market potential such as BPD”, 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 antiinflammatory effects in severe Covid-19 patients. Vafidemstat is being investigated in neuropsychiatric disorders in two doubleblind, 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.
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