ORYZON to Present Preliminary Blinded Aggregate Safety Data From Vafidemstat's Ongoing Phase IIb PORTICO Trial in Borderline Personality Disorder
MADRID, Spain and BOSTON, Sept. 16, 2022 (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, today presents initial preliminary blinded aggregate safety data from its ongoing Phase IIb PORTICO trial, investigating vafidemstat in Borderline Personality Disorder (BDP), in a 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. Forty one (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.
Dr. Douglas Faller, Oryzon’s Global CMO, stated: “Oryzon welcomes the opportunity to update the scientific community on our PORTICO trial of vafidemstat, an epigenetic pharmaceutical, in patients suffering from BPD. The results of the interim safety analysis are very encouraging, and support our program to develop a novel, effective and safe treatment for these underserved individuals.” Dr Michael Ropacki, Oryzon’s CNS CMO remarked: “With no approved treatments and a high rate of self-harming and suicidal behavior, BPD remains a high unmet medical need. I am extremely pleased that vafidemstat has continued to be safe and well-tolerated in the Phase IIb PORTICO clinical trial to-date. The aggregate of safety data across 9 completed and ongoing vafidemstat clinical trials has been consistent in the safety profile of this novel epigenetic LSD1 inhibitor for the treatment of psychiatric diseases.”
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 160 patients distributed between two arms. PORTICO has an adaptive design with a pre-defined interim analysis to adjust the sample size in case of excessive variability around the endpoints.
Oryzon’s oral communication at ECMH is entitled “PORTICO, a double-blind, randomized placebo-controlled, adaptive Phase IIb trial with vafidemstat in Borderline Personality Disorder”. A copy of the presentation is available here.
For more information about ECMH-2022, please visit ECMH’s website.