ORYZON announces U.S. patent grant for vafidemstat in borderline personality disorder (BPD)

Oryzon Genomics, 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.

Vafidemstat se encuentra en una fase avanzada de desarrollo clínico para el tratamiento de la agresión en trastornos psiquiátricos, con un ensayo clínico de Fase III en preparación para el tratamiento de la agresión asociada al TLP y un nuevo ensayo clínico de Fase II previsto en trastorno del espectro autista (TEA). Este ensayo se centrará en subpoblaciones de pacientes con TEA definidas genéticamente, en particular en personas con síndrome de Phelan-McDermid (PMS). Además, está en marcha un ensayo clínico de Fase II en esquizofrenia centrado en los síntomas negativos, entre los que el retraimiento social constituye uno de los más destacados.