ORYZON further strengthens vafidemstat’s patent portfolio with new decisions to grant

Oryzon Genomics, S.A., a clinical-stage biopharmaceutical company and global leader in epigenetics, today announced that it has received new decisions to grant for patent applications in South Korea, the Philippines, New Zealand and Mexico, further strengthening its extensive patent portfolio for vafidemstat, Oryzon’s LSD1 inhibitor in clinical development for psychiatric and neurodevelopmental disorders.

The Korean and Philippine Patent Offices have issued decisions to grant for patent applications KR10-2021 7028149 and PH1-2021-552251, respectively, both titled “Methods of treating borderline personality disorder.” The allowed claims cover the use of vafidemstat for the treatment of non-aggressive symptoms of borderline personality disorder (BPD), complementing Oryzon’s patent protection relating to aggression. Corresponding patents have already been granted or allowed in Australia, Canada, Europe, Hong Kong, Japan, Malaysia, Mexico, Russia, Singapore, South Africa and the United States. The U.S. patent is expected to remain in force until at least 2043, including 1,095 days of Patent Term Adjustment, while the non-U.S. patents are expected to remain in force until at least 2040, excluding any potential patent term extensions or equivalent adjustments.

In addition, the New Zealand Patent Office has issued a decision to grant for patent application NZ760665, which belongs to a separate patent family covering the use of vafidemstat for the treatment of aggression and social withdrawal. Corresponding patents have already been granted or allowed in Australia, Canada, Europe, Hong Kong, Israel, Japan, South Korea, Malaysia, the Philippines and Russia, with additional applications pending in other jurisdictions. These patents are expected to remain in force until at least 2038, excluding any potential patent term extensions or adjustments.

Oryzon has also received a decision to grant from the Mexican Patent Office for patent application MX/A/2022/002420, titled “Methods of treating autism spectrum disorder”. The allowed claims cover the use of vafidemstat for the treatment of certain non-aggressive symptoms of autism spectrum disorder (ASD). A corresponding patent has already been granted in Japan, with applications pending in other countries. Once granted, this Mexican patent will remain in force until at least 2040, excluding any potential patent term extensions.

“These new patent allowances represent another important step in strengthening the global intellectual property protection of vafidemstat across multiple therapeutic indications,” said Neus Virgili, Oryzon's Chief IP Officer. “By expanding our patent coverage in international markets and across distinct clinical applications, we continue to build a broad and durable IP portfolio that supports vafidemstat's long-term development and commercial potential.”

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. The compound is also being evaluated in the ongoing randomized, double-blind, placebo-controlled Phase IIb EVOLUTION trial targeting negative symptoms of schizophrenia, among which social withdrawal is one of the most prominent. In parallel, Oryzon is expanding vafidemstat's development into genetically defined patient populations through its precision medicine strategy, including a recently approved Phase II clinical trial in ASD focused on patients with Phelan-McDermid syndrome (PMS).