ORYZON Strengthens Regulatory Strategy with the Appointment of Dr. Iman Barilero as Senior Advisor for Regulatory Affairs

Core Insights - Oryzon Genomics has announced a strategic collaboration with Dr. Iman Barilero as Senior Advisor for Regulatory Affairs to advance its Phase III clinical program for vafidemstat in Borderline Personality Disorder (BPD) [1][4] Company Overview - Oryzon Genomics is a clinical-stage biopharmaceutical company founded in 2000 in Barcelona, Spain, and is a leader in epigenetics, focusing on personalized medicine for CNS disorders and oncology [5] - The company has a clinical portfolio that includes two LSD1 inhibitors: vafidemstat (Phase III-ready) and iadademstat (Phase II) [5] Regulatory Expertise - Dr. Iman Barilero brings over 30 years of global regulatory leadership experience, particularly in CNS, neuropsychiatry, and rare diseases, with a successful track record in guiding Phase II-III programs and securing global approvals [2][3] - Her previous role as Vice President at Lundbeck involved leading global regulatory strategies for breakthrough therapies targeting various CNS disorders [3] Clinical Development - Vafidemstat is currently being evaluated in a double-blind, randomized, placebo-controlled Phase IIb trial (EVOLUTION) for its potential to improve negative symptoms in schizophrenia [4][8] - The company is also preparing a clinical trial for vafidemstat in Autism Spectrum Disorder (ASD) and has conducted several Phase IIa trials with positive results in psychiatric disorders [8] Strategic Goals - The collaboration with Dr. Barilero aims to enhance regulatory dialogue with the FDA and provide strategic guidance across clinical development programs [7] - Oryzon's pipeline includes programs targeting schizophrenia and ASD, with a focus on advancing its late-stage pipeline in BPD and schizophrenia [4][8]