Oryzon Genomics Appoints Regulatory Expert to Advance Vafidemstat Phase III Program in Borderline Personality Disorder
核心洞察
Oryzon Genomics (搜索) has appointed Dr. Iman Barilero as Senior Advisor for Regulatory Affairs to support the advancement of vafidemstat into Phase III trials for Borderline Personality Disorder (搜索).
Dr. Barilero brings over 30 years of global regulatory leadership experience across CNS disorders and has previously secured first-in-class approvals at Lundbeck.
Vafidemstat is an oral LSD1 (搜索) inhibitor that has shown positive results in Phase IIa trials and is currently being evaluated in multiple CNS conditions including schizophrenia (搜索) and autism spectrum disorder.
Oryzon Genomics (搜索) has strengthened its regulatory capabilities with the strategic appointment of Dr. Iman Barilero as Senior Advisor for Regulatory Affairs, positioning the company to advance its lead CNS asset vafidemstat into Phase III development for Borderline Personality Disorder (搜索) (BPD). The appointment comes as the clinical-stage biopharmaceutical company prepares to address regulatory requirements identified by the FDA for its late-stage CNS programs.
Regulatory Leadership with Proven Track Record
Dr. Barilero brings over 30 years of global regulatory leadership across CNS, neuropsychiatry, immuno-oncology, and rare diseases. Her expertise includes direct engagement with major health authorities including the FDA (CBER & CDER), EMA, PMDA, CFDA, Health Canada, and ANVISA. Her career spans academia, big pharma, and emerging biotechs, with a notable tenure as Vice President, Head of Global Regulatory Science for CNS at Lundbeck.
At Lundbeck, Dr. Barilero led global regulatory strategies for breakthrough therapies targeting depression (搜索), bipolar disorder (搜索), schizophrenia (搜索), stroke, Alzheimer's disease (搜索), Parkinson's disease (搜索), and alcohol dependence. She played a pivotal role in securing first-in-class label claims for cognition in major depressive disorder with Brintellix/Trintellix, achieving approvals across the US, EU, Japan, China, and other major markets.
Strategic Focus on Phase III Advancement
"This new collaboration forms part of Oryzon's strategic reinforcement of its Medical, Regulatory, and Strategic functions," said Dr. Carlos Buesa, CEO of Oryzon. "Dr. Barilero's deep expertise in CNS drug development and global regulatory strategy will be invaluable as we advance vafidemstat into Phase III and address all areas identified by the FDA. Her leadership will help ensure the company is fully prepared to advance its late-stage pipeline in BPD and Schizophrenia (搜索), and well as our early-stage program in ASD."
Dr. Barilero expressed enthusiasm about joining the company at this critical juncture. "I'm thrilled to join Oryzon at this pivotal moment as Senior Advisor for Regulatory Affairs," said Dr. Barilero, Founder of Kulli Global Development consultancy. "Vafidemstat holds significant promise for patients with CNS disorders, and I look forward to contributing my experience in global regulatory strategy to help advance its development and ensure strategic alignment with FDA."
Vafidemstat's Clinical Development Program
Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 (搜索) inhibitor that acts on multiple levels to reduce cognitive impairment, including memory loss and neuroinflammation, while providing neuroprotective effects. In animal studies, vafidemstat not only restores memory but reduces exacerbated aggressiveness in SAMP8 mice, a model for accelerated aging and Alzheimer's disease (搜索), to normal levels. The compound also reduces social avoidance and enhances sociability in murine models.
The company has completed multiple Phase IIa clinical trials with positive results. These include the REIMAGINE trial in aggressiveness in patients with different psychiatric disorders and the REIMAGINE-AD trial in aggressive/agitated patients with moderate or severe Alzheimer's disease (搜索). Additional completed Phase IIa trials include the ETHERAL trial in patients with mild to moderate Alzheimer's disease, where a significant reduction of the inflammatory biomarker YKL40 was observed after 6 and 12 months of treatment.
Following completion of the global, randomized, double-blind Phase IIb PORTICO trial in Borderline Personality Disorder (搜索), with final data presented at ECNP-2024, vafidemstat is advancing as a Phase III-ready asset for agitation/aggression in BPD, with the Phase III protocol already submitted.
Expanding CNS Pipeline
Oryzon's ambitious CNS pipeline extends beyond BPD to include programs in schizophrenia (搜索) and Autistic Spectrum Disorder (搜索) (ASD). Vafidemstat is currently being evaluated in EVOLUTION, a double-blind, randomized, placebo-controlled Phase IIb trial assessing its potential to improve negative symptoms in schizophrenia, with recruitment ongoing. Additionally, a clinical trial in ASD is in preparation.
The company is also deploying a CNS precision medicine approach with vafidemstat in genetically defined patient subpopulations of certain CNS disorders, as well as in neurodevelopmental syndromes. Oryzon is preparing a clinical trial in aggression in autistic conditions like Phelan-McDermid syndrome.
Founded in 2000 in Barcelona, Spain, Oryzon is a clinical-stage biopharmaceutical company and European leader in epigenetics, with a focus on personalized medicine in CNS disorders and oncology. The company maintains an advanced clinical portfolio with two LSD1 (搜索) inhibitors: vafidemstat in CNS (Phase III-ready) and iadademstat in oncology (Phase II).