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, presents initial preliminary blinded aggregate safety data from its ongoing Phase IIb PORTICO trial, investigating vafidemstat in Borderline Personality Disorder (BDP), in an oral communication at the 10th European Conference on Mental Health (ECMH), being held in Lisbon (Portugal) on September 13-16.
Blinded aggregate safety data presented at ECMH correspond to the initial randomized 43 patients (data cut-off, 30 June 2022). There were no reported serious adverse events. 41 adverse reactions, affecting 12 patients treated either with vafidemstat or placebo were reported, most of them mild and none reported as severe, with none leading to treatment discontinuation or patient withdrawal. In July 2022, the independent Data Monitoring Committee for PORTICO reviewed the available safety data and determined that the trial should continue. PORTICO safety data is aligned with aggregated safety data collected from 7 completed vafidemstat clinical trials, in which more than 300 subjects have been treated with the drug. Current data of PORTICO continue to support that vafidemstat is safe and well-tolerated. An independent interim analysis to assess the signal size and futility is expected to be done in 1Q23 with the data of the first 90 patients that will have concluded at least 2/3 of the trial.
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