Breakthrough Phase IIa Results with Vafidemstat in Psychiatry
Significant Advancements in Psychiatric Treatments with Vafidemstat
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a pioneering biopharmaceutical company, has announced promising developments following the final results from the Phase IIa REIMAGINE study. This research evaluated the safety and preliminary efficacy of vafidemstat in addressing agitation and aggression in patients with borderline personality disorder (BPD), attention-deficit/hyperactivity disorder (ADHD), and autistic spectrum disorder (ASD). These findings, which have been published online in the journal Psychiatry and Clinical Neurosciences, mark a significant milestone for the company.
Study Overview and Results
The REIMAGINE study was conducted as a Phase IIa, single-center, open-label, one-arm basket trial. It aimed to assess the safety and efficacy of vafidemstat, a CNS-optimized LSD1 inhibitor. The trial included adult patients from the aforementioned categories who received 1.2 mg/day of vafidemstat for a duration of eight weeks. The results demonstrated that vafidemstat was safe for patients and well-tolerated while providing a substantial reduction in agitation and aggression across all groups examined in the study.
Clinical Benefits Across Diverse Patient Populations
The outcomes of the study revealed that vafidemstat provided a relevant clinical benefit. It successfully alleviated agitation and aggression in patients suffering from BPD, ADHD, and ASD. Additionally, significant improvements were observed in non-aggressive features and overall disease indicators among participants. The results established a solid foundation for the continued development of vafidemstat.
Future Directions for Vafidemstat
Building upon the breakthrough findings of the REIMAGINE study, Oryzon is progressing towards the next phases of clinical trials. Following a successful Phase IIb trial and valuable consultations with the U.S. Food and Drug Administration (FDA), Oryzon is geared up to initiate the PORTICO-2 Phase III trial. This trial will evaluate the efficacy of vafidemstat in managing agitation and aggression specifically in patients diagnosed with BPD. Dr. Carlos Buesa, Oryzon’s CEO, expressed optimism about vafidemstat’s potential, emphasizing that if successful, it could significantly enhance the quality of life for those affected by this challenging disorder.
A Commitment to Research and Development
Oryzon is deeply committed to furthering research in psychiatric treatments, focusing on novel drug mechanisms like vafidemstat. With a well-established team comprising industry veterans and experts, Oryzon is dedicated to exploring groundbreaking approaches in the realm of CNS disorders. The company plans to scrutinize vafidemstat for additional applications, potentially extending to other CNS disorders.
About Oryzon Genomics
Founded in 2000 in Barcelona, Oryzon is a clinical stage biopharmaceutical company specializing in epigenetics and personalized medicine. As a leader in this space, Oryzon aims to address substantial needs within the fields of CNS disorders and oncology. With a robust pipeline that includes two LSD1 inhibitors and various other epigenetic targets like HDAC-6, Oryzon is well-positioned to deliver innovative treatments.
Continuing Progress in Clinical Trials
Oryzon's ongoing clinical investigations of vafidemstat extend beyond psychiatric disorders. The drug is also under review in the Phase IIb EVOLUTION trial, aimed at treating negative symptoms of schizophrenia. Further trials are in place that include indications for disorders associated with aggressive behavior, addressing an area of significant clinical need.
Frequently Asked Questions
What is vafidemstat?
Vafidemstat (ORY-2001) is an oral LSD1 inhibitor designed to mitigate cognitive impairment and reduce aggression in various CNS disorders.
What was the primary focus of the REIMAGINE study?
The REIMAGINE study focused on evaluating the safety and efficacy of vafidemstat in patients with agitation and aggression across multiple psychiatric conditions.
How did vafidemstat perform in the study?
The results indicated that vafidemstat was safe and well-tolerated, significantly reducing agitation and aggression in participants with BPD, ADHD, and ASD.
What are Oryzon's future plans for vafidemstat?
Oryzon is preparing to initiate the PORTICO-2 Phase III trial to further investigate vafidemstat’s efficacy in managing symptoms of BPD.
Is Oryzon involved in any other clinical research?
Yes, Oryzon is actively exploring vafidemstat's effectiveness in various trials addressing additional psychiatric and neurological conditions, expanding its research portfolio.
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