Oryzon Genomics - FDA aligns on Phase III BPD plans

Oryzon Genomics has confirmed the FDA’s alignment with its proposed Phase III programme for vafidemstat in borderline personality disorder (BPD). Notably, the FDA acknowledged agitation and aggression (A/A) as a therapeutic indication and, as such, the State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger may be used as a primary endpoint for Phase III (PORTICO-2). We note that vafidemstat showed statistically significant benefit by this measure in the prior Phase IIb PORTICO trial. We view the news as encouraging and believe there is a sizeable opportunity for Oryzon to develop an effective treatment for BPD, for which there are currently no approved drugs. Next steps are to submit a full trial protocol for PORTICO-2 to the FDA (expected within Q125), before a potential trial launch from H225, contingent on regulatory clearance and providing that there are no other delays.