Oryzon Receives FDA Feedback On Phase III Vafidemstat Trial In Borderline Personality Disorder

Oryzon Genomics, S.A., a leading clinical-stage biopharmaceutical company in the field of epigenetics, announced that it has received written feedback from the U.S. Food and Drug Administration (FDA) regarding the Phase III clinical trial protocol for vafidemstat in borderline personality disorder (BPD). The feedback addressed several key components, including endpoint selection and non-clinical aspects of the study.

“We appreciate the FDA’s constructive feedback and view it as an opportunity to optimize our Phase III program for vafidemstat in borderline personality disorder,” said Carlos Buesa, Chief Executive Officer of Oryzon. “Aligning our study with the Agency’s recommendations will strengthen the trial design and, ultimately, our ability to bring a potential first-in-class therapy to patients living with BPD. With the support of our international clinical advisors and our team of regulatory specialists, the company is actively revising the protocol and we look forward to continued engagement with the FDA as we finalize the next steps”.

The company stated that it will integrate the FDA’s recommendations into a revised Phase III protocol and resubmit it for further review. Oryzon emphasized that such iterative discussions are a normal part of regulatory interactions aimed at ensuring that clinical programs meet FDA standards and scientific rigor before advancing to pivotal trials.

Meanwhile, Oryzon continues to progress its other central nervous system (CNS) programs as planned. Vafidemstat is also being studied in the ongoing Phase IIb EVOLUTION trial, a double-blind, randomized, placebo-controlled study evaluating its potential to improve negative symptoms in schizophrenia, further broadening the compound’s potential therapeutic reach.