ORYZON Announces U.S. Patent Grant for Vafidemstat in Borderline Personality Disorder (BPD)

• Granted claims cover the use of vafidemstat for treating non-aggressive symptoms of BPD
• U.S. patent to expire in March 2043, including 1,095 days of Patent Term Adjustment
• Notice of allowance also received in a corresponding Canadian patent application
  

MADRID and CAMBRIDGE, Mass., July 08, 2026 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 12,673,044, entitled “Methods of treating borderline personality disorder”. The granted claims cover methods of treating non-aggressive symptoms of borderline personality disorder (BPD) using LSD1 inhibitors, including vafidemstat, complementing Oryzon’s patent portfolio covering the treatment of aggression.

The patent is expected to expire in March 2043, including 1,095 days of Patent Term Adjustment (PTA) awarded by the USPTO to compensate for delays during patent prosecution. This estimate does not include any potential Patent Term Extension (PTE) that may become available following regulatory review, if applicable.

A Decision to Grant has also recently been issued for a corresponding Canadian patent application in this patent family, with allowed claims covering the use of vafidemstat for the treatment of non-aggressive symptoms of BPD. In addition to the U.S. and Canadian developments, corresponding patents have been granted or allowed in Australia, Europe, Japan, Malaysia, Mexico, Russia, Singapore, and South Africa, with additional applications pending in other jurisdictions. The non-U.S. patents are expected to remain in force until at least 2040, excluding any potential patent term extensions or equivalent adjustments.

"The grant of this U.S. patent, including 1,095 days of PTA, significantly extends the expected patent protection for vafidemstat in borderline personality disorder. Together with the recent notice of allowance in Canada and other granted or allowed patents in key jurisdictions, this strengthens Oryzon’s intellectual property position for vafidemstat and supports its long-term development and commercial potential in an area of significant unmet medical need," said Neus Virgili, Oryzon's Chief IP Officer.

Oryzon also holds a separate patent family directed to the treatment of aggression and social withdrawal, with patents granted or allowed in Australia, Canada, Europe, Hong Kong, Israel, Japan, South Korea, Malaysia, the Philippines, and Russia, and additional applications pending in other jurisdictions. The European Patent Office (EPO) recently granted a second European patent within this family, EP4512473, which includes specific claims covering, among others, the use of vafidemstat for the treatment of aggression associated with BPD or autism spectrum disorder (ASD), as well as the treatment of social withdrawal associated with schizophrenia. These patents are expected to remain in force until at least 2038, excluding any potential patent term extensions or adjustments.

Vafidemstat is in advanced clinical development for the treatment of aggression in psychiatric disorders, with a Phase III trial in preparation for aggression in BPD and a new Phase II trial under preparation in aggression in ASD. The ASD trial will focus on genetically defined ASD subpopulations, in particular individuals with Phelan-McDermid syndrome (PMS). In addition, a Phase II trial is ongoing in schizophrenia, with a focus on negative symptoms, of which social withdrawal is one of the most prominent.

About Oryzon

Founded in 2000 and headquartered in Barcelona, Spain, Oryzon (ISIN: ES0167733015) is a clinical-stage biopharmaceutical company and a European leader in epigenetics, with a strong focus on personalized medicine for central nervous system (CNS) disorders and oncology. Oryzon’s team comprises highly experienced pharmaceutical professionals based in Barcelona, Boston, and New Jersey. The Company has an advanced clinical portfolio built around two LSD1 inhibitors: iadademstat, its oncology/hematology program, with several ongoing Phase I and II studies and which has demonstrated strong preliminary clinical activity in acute myeloid leukemia, including a 100% overall response rate (ORR) in first-line AML; and vafidemstat, its lead CNS program, which is Phase III–ready in Borderline Personality Disorder (BPD). In addition, Oryzon is advancing a broader epigenetics pipeline targeting other mechanisms, including HDAC6, for which the Company has nominated ORY-4001 as a clinical candidate for potential development in Charcot–Marie–Tooth disease (CMT), amyotrophic lateral sclerosis (ALS), and other neurological disorders. The Company also operates a robust platform for biomarker identification and target validation across malignant and neurological diseases. For more information, visit www.oryzon.com

About Vafidemstat
Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor with potential to address neuropsychiatric disorders through epigenetic modulation. In preclinical studies, vafidemstat has demonstrated effects on cognition, neuroinflammation, aggression, and social behavior, as well as neuroprotective and anti-inflammatory activity across multiple CNS disease models. Oryzon has completed several Phase II clinical trials with vafidemstat, including the REIMAGINE and REIMAGINE-AD trials in aggression in patients with different psychiatric disorders and in aggressive/agitated patients with moderate or severe AD, respectively, with positive clinical results reported in both trials. Following completion of the global randomized double-blind Phase IIb PORTICO trial in borderline personality disorder (BPD), vafidemstat is advancing as a Phase III-ready asset for agitation/aggression in BPD (PhIII in preparation). Vafidemstat is also being evaluated in the ongoing double-blind, randomized, placebo-controlled Phase IIb EVOLUTION trial in negative symptoms of schizophrenia. In addition, Oryzon is also deploying a CNS precision medicine approach with vafidemstat in genetically defined patient subpopulations of certain CNS disorders, as well as in neurodevelopmental syndromes, including preparations for a new clinical trial in aggression in autistic conditions such as Phelan-McDermid syndrome.

FORWARD-LOOKING STATEMENTS
This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events, or otherwise. This document does not constitute an offer or invitation to purchase or subscribe shares in accordance with the provisions of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017, and/or the restated text of the Securities Market Law, approved by Law 6/2023 of 17 March, and its implementing regulations. Nothing in this document constitutes investment advice. In addition, this document does not constitute an offer of purchase, sale or exchange, nor a request for an offer of purchase, sale or exchange of securities, nor a request for any vote or approval in any jurisdiction. The shares of Oryzon Genomics, S.A. may not be offered or sold in the United States of America except pursuant to an effective registration statement under the Securities Act of 1933 or pursuant to a valid exemption from registration. 

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.