Oryzon's Innovative Vafidemstat Data Showcase at ECNP Congress
Oryzon Genomics Presents Final Data from PORTICO Trial
Oryzon Genomics, S.A., a clinical-stage biopharmaceutical company focused on leveraging epigenetics, recently announced the final data from its Phase IIb PORTICO trial of vafidemstat for treating patients with Borderline Personality Disorder (BPD). This important update was shared during the European College of Neuropsychopharmacology (ECNP) Congress, emphasizing the significant advancements made in mental health therapeutics.
Key Improvements Observed in Trial Results
The PORTICO trial produced notable improvements in various clinical measurements related to BPD. Significant enhancements were observed in the State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger scale, demonstrating a strong reduction in agitation and aggression among participants receiving vafidemstat compared to those on placebo. Specifically, the trial reported a statistical significance with a p-value of 0.0071, showing a considerable decline at Weeks 8–12.
Overall Disease Severity Reduction
Furthermore, the Borderline Evaluation of Severity Tool (BEST) highlighted improvements in overall disease severity with a p-value of 0.0260. This indicates that the vafidemstat treatment may offer a robust therapeutic approach for managing symptoms associated with BPD more effectively than previously reported data.
Vafidemstat Effectiveness and Safety
Vafidemstat has consistently shown favorable results in multiple efficacy endpoints throughout the PORTICO trial. As highlighted by a T-Forest plot analysis, vafidemstat provided a significant treatment effect over placebo, underscoring its potential as a novel therapy for BPD. Additionally, the Global Statistical Test (GST) results further confirmed a global treatment effect favoring vafidemstat, reinforcing its therapeutic benefits in BPD management.
Positive Interaction with FDA
In a recent end-of-Phase II meeting, Oryzon presented these compelling results to the FDA, discussing the potential for a registrational Phase III study for vafidemstat. The encouraging data not only point to immediate preparations for further clinical trials but also put Oryzon in a unique position as a frontrunner in developing an approved pharmacological treatment for BPD.
Feedback from Oryzon's Leadership
Dr. Michael Ropacki, Oryzon's Chief Medical Officer, expressed enthusiasm over the results, stating that they indicate a promising new treatment avenue for individuals suffering from BPD. The therapeutic mechanism of action, based on epigenetics, presents a compelling choice devoid of the typical side effects associated with most current off-label medications. This could significantly impact patients’ lives, showcasing vafidemstat as a groundbreaking option in managing BPD.
Oryzon’s Vision for Future Research
Oryzon is heavily invested in advancing its research into BPD and other CNS disorders. The company aims to explore and develop further clinical trials, driven by compelling evidence from the PORTICO study, to refine treatment options for patients. Their ongoing research and commitment to innovation in the field of epigenetics position Oryzon to play a critical role in improving patient care.
Frequently Asked Questions
What is vafidemstat?
Vafidemstat is an oral, CNS-optimized LSD1 inhibitor designed to treat various CNS disorders, including BPD.
What were the key findings from the PORTICO trial?
The trial showed significant reductions in agitation and aggression among patients treated with vafidemstat compared to placebo.
How does vafidemstat work?
Vafidemstat works through an epigenetic mechanism, which helps manage symptoms without the common side effects of other treatments.
What is the future for vafidemstat?
Oryzon aims to prepare for a Phase III trial following positive FDA feedback based on PORTICO's results.
How significant are the results of the PORTICO trial?
The trial results are groundbreaking, marking the first time significant statistical outcomes have been achieved in a randomized Phase IIb trial for BPD.
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