Oryzon Advances Vafidemstat For Borderline Personality Disorder, Finalizes Phase III Trial Endpoints

Oryzon Genomics, S.A., a clinical-stage biopharmaceutical company specialising in epigenetics, has finalised the primary and key secondary endpoints for its upcoming Phase III clinical trial of vafidemstat in Borderline Personality Disorder (BPD). This milestone was achieved in collaboration with Oryzon’s newly established Clinical Advisory Board (CAB), which includes leading psychiatry experts specialising in psychiatric research and clinical trials. The CAB was crucial in ensuring the Phase III trial design met FDA expectations. 

“We are honoured to collaborate with such a distinguished panel of experts as we advance vafidemstat into Phase III development. Their expertise in psychiatric disorders and clinical trial methodology strengthens our program and ensures we are well-prepared for the next regulatory interactions. Addressing aggression and agitation in BPD remains an urgent medical need, and we are committed to delivering innovative solutions for these patients,” said Dr. Carlos Buesa, Chief Executive Officer of Oryzon

He further added, “These are the right experts to help us shape a Phase III program that is both scientifically rigorous and clinically meaningful. It is particularly reassuring that their expert medical opinion and years of practice recognise aggression as one of the most debilitating aspects of many psychiatric disorders, particularly borderline personality disorder. Their contributions have been instrumental in defining the primary and secondary endpoints that will generate robust data for regulatory submissions.”

It incorporates well-established assessment scales to evaluate agitation and aggression in BPD patients. This progress follows the successful Phase IIb PORTICO trial, which received positive feedback from the FDA, further supporting the advancement of vafidemstat. With these developments, Oryzon is on track to submit the Phase III trial protocol for regulatory review in the first half of 2025. This marks a significant step forward in bringing vafidemstat closer to potential approval for treating BPD.