Oryzon says FDA’s feedback supports start of vafidemstat Phase III trial

Spanish epigenetics firm Oryzon Genomics (BME: ORY) has announced the receipt of the official meeting minutes from a recent End-of-Phase II meeting for vafidemstat in borderline personality disorder (BPD) with the US Food and Drug Administration (FDA).

Based on the positive feedback received, Oryzon, a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, will now move forward with preparing a full PORTICO-2 Phase III trial protocol to be submitted to the FDA for study approval.

At the End-of-Phase II meeting with the FDA, held in late August, various aspects of vafidemstat’s development plan were thoroughly evaluated and discussed. The minutes cover the FDA’s opinion on the suitability of the vafidemstat program to date in several critical areas: i) preclinical data, ii) toxicology, iii) clinical pharmacology, and iv) clinical studies. The meeting minutes confirm that both the company and the FDA reached clarity on several key elements of the PORTICO-2 Phase III clinical trial design for vafidemstat.