ORYZON presents blinded aggregate safety data from vafidemstat’s ongoing Phase IIb PORTICO trial in Borderline Personality Disorder

• At the 36th European College of Neuropsychopharmacology congress (ECNP-2023)
  

MADRID, Spain and BOSTON, Oct. 10, 2023 (GLOBE NEWSWIRE) -- 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 the company presented an update on vafidemstat’s ongoing Phase IIb PORTICO trial in borderline personality disorder (BPD) at the 36th European College of Neuropsychopharmacology (ECNP) Congress, held on October 7-10 in Barcelona, Spain.

Oryzon presented a poster communication entitled “PORTICO – Double-blind, randomized placebo-controlled, adaptive phase IIb trial with vafidemstat in borderline personality disorder – aggregated baseline characteristics, demographics and safety”, which was presented by Dr. Michael Ropacki, Oryzon’s CMO for CNS.

PORTICO enrolled the last patient in July 2023. The data presented at ECNP-2023 correspond to the analysis of aggregated blinded safety data cut as of August 23, 2023. As of September 2023, PORTICO randomized 210 participants, and 131 of the originally planned participants (N = 150) already completed the trial. Results obtained confirm that PORTICO enrolled a representative real-world BPD population allowing common comorbidities and concomitant medications that are typically exclusionary in other BPD trials, as well as allowed subjects to receive psychotherapy during the trial. The screen failure and dropout rates were lower than in the most recent BPD clinical trial. Finally, the aggregated blinded safety data on the fully enrolled sample supports that vafidemstat has been extremely safe and well-tolerated, with a low number of discontinuations (2%) due to treatment-emergent adverse events (TEAEs) and 0% due to serious TEAEs (STEAEs). Only one serious TEAE deemed severe was reported, which fully recovered/resolved during the study.

Dr. Ropacki stated: “PORTICO is a global BPD clinical trial evaluating vafidemstat that enrolled a real-world representative BPD population. It is hoped that the PORTICO efficacy results, expected early next year, together with the excellent safety profile observed to-date will support vafidemstat as a potential effective new treatment option in a population with high unmet need and no approved drug therapy.”