Oryzon Genomics - PORTICO update with planned FDA EoP2

Oryzon Genomics has announced top-line results for the Phase IIb trial (PORTICO) assessing vafidemstat in borderline personality disorder (BPD), and while the primary endpoints (Borderline Personality Disorder Checklist (BPDCL) and Clinical Global Impression - Severity Agitation/ Aggression (CGI-S A/A)) did not reach statistical significance, vafidemstat was favoured over placebo in all efficacy measures, with nominal statistical significance in two key secondary endpoints (Borderline Evaluation of Severity (BEST) and State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger). Further, the drug was found to be safe and well-tolerated, consistent with prior studies. Management plans to conduct a detailed analysis of the trial data across the coming months and intends to request an end-of-Phase II (EoP2) meeting with the FDA in early Q224 to discuss a potential registrational Phase III programme. There are currently no approved drugs for this indication and hence gold-standard endpoints are yet to be established. We therefore believe that there is still a significant opportunity for Oryzon in this space, however, further clinical progression will be heavily reliant on the EoP2 meeting request and outcome.

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