ORYZON announces positive results from planned interim analysis of PORTICO, a Phase 2b adaptive trial in Borderline Personality Disorder

Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical needs, announced today positive outcome from its planned, prespecified interim analysis of its Phase 2b trial, PORTICO, with vafidemstat for borderline personality disorder (BPD). These results were determined by an Independent Data Monitoring Committee (IDMC) that met on Thursday, March 30, 2023. Based planned interim analysis of the first 90 participants who completed treatment, the trial was determined to be non-futile. Based in the efficacy and safety data, the IDMC recommended to continue the trial without any modifications.

"The planned interim analysis results on the PORTICO independent multiple primary endpoints provides additional support that vafidemstat is a safe and well-tolerated drug with potential to effectively treat BPD and potentially other difficult-to-treat psychiatric disorders. With the support of our investigators and team, we anticipate topline data in early 2024. At that time, the team will carefully assess the primary, as well as secondary and exploratory, endpoints. PORTICO is an ambitious trial, and our hope is that this study will provide additional insights to help guide future vafidemstat CNS clinical development efforts including follow on Phase III BPD clinical trials,” said Dr. Michael Ropacki, Chief Medical Officer for CNS.

Dr. Douglas V. Faller, Global Chief Medical Officer, said “We are very pleased to continue to advance vafidemstat through clinical trials, and we remain hopeful that vafidemstat will ultimately provide benefit to the psychiatric patient community. In addition to PORTICO, we also have an ongoing trial in schizophrenia, and we are expecting to start a program this year in personalized medicine in Kabuki Syndrome, a rare neurodevelopmental syndrome, wherein the therapeutic mechanism of action for LSD1 inhibition has been well characterized.”

"Oryzon is the only company exploring the potential of targeting LSD1 in CNS disorders. These positive interim data are an important clinical development milestone for our CNS program. We are looking forward to read-out the top-line trial results in the near future. We are very grateful for the support and commitment from the participants and the study investigators," said Dr. Carlos Buesa, Chairman and Chief Executive Officer of Oryzon.

PORTICO (EudraCT No.: 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a multicenter, double-blind, randomized, placebo-controlled, Phase IIb trial to evaluate the efficacy and safety of vafidemstat in adult BPD patients. The trial has two primary independent objectives: to reduce agitation and aggression and an overall improvement of BPD. The trial is currently actively recruiting patients in Europe and in the US and aims to include about 188 patients distributed between two arms.

More information in the file attached