ORYZON Announces Topline Results from Phase IIb PORTICO Study of Vafidemstat in Borderline Personality Disorder (BPD)

Company to host Conference Call and live Webcast on Sunday, January 7, 2024 at 5:30 pm PT.

An executive summary of the data to be presented at the 7th Sachs Annual Neuroscience Innovation Forum, on January 7 at 3:30 pm PT, at the Marine’s Memorial Club in San Francisco (USA).

• Results across all efficacy endpoints consistently favored vafidemstat over placebo. Global Statistical Test (GST p-values) confirms consistent trend across efficacy endpoints
  
• The primary endpoints, improvement in Borderline Personality Disorder Checklist (BPDCL) and in agitation/aggression by the Clinical Global Impression – Severity Agitation/Aggression (CGI-S A/A), did not reach statistical significance
  
• Nominal statistical significance was achieved on the secondary endpoint Borderline Evaluation of Severity (BEST), an overall measure of BPD disease severity, at weeks 8-12 (p = 0.042)
  
• Nominal statistical significance was also achieved on the secondary endpoint State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger, a measure of agitation and aggression, at weeks 8-12 (p = 0.026)
  
• Vafidemstat was safe and well tolerated, consistent with the overall safety profile to date
  
• Based on the efficacy and safety results, Oryzon intends to request an FDA end-of-Phase II meeting to discuss a registrational Phase III study for the treatment of BPD
  

MADRID, Spain and BOSTON, Jan. 05, 2024 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with a strong unmet medical need, today announced topline results from the Phase IIb PORTICO trial, evaluating the efficacy and safety of vafidemstat in Borderline Personality Disorder (BPD).

Webcast/Conference Call Information

ORYZON will host a conference call and webcast on January 7, 2024 at 5:30 pm Pacific Time to discuss PORTICO Phase IIb results. To register for the event please click here. A replay of the webcast will be available on the company’s website after the event and will be archived for approximately one month.

Summary of Efficacy Data

A mixed model repeated measures (MMRM) completed on the multiple independent primary endpoints for overall disease as measured by the Borderline Personality Disorder Checklist (BPDCL) and for agitation and aggression by the Clinical Global Impression-Severity focused on Agitation/Aggression (CGI-S A/A) across weeks 8-12 showed for both endpoints a consistent reduction over the values in the placebo group throughout the treatment, which did not reach statistical significance (p = 0.41 and p = 0.25, respectively).