ORYZON Receives Feedback From the FDA in Response to the Submitted Phase III Protocol in Borderline Personality Disorder

Core Insights - Oryzon Genomics has received feedback from the FDA regarding its Phase III protocol for vafidemstat in borderline personality disorder (BPD), which will be revised and resubmitted [2][3] - The company views the FDA's feedback as an opportunity to enhance the trial design and improve the chances of bringing a first-in-class therapy to patients with BPD [3] Company Overview - Oryzon Genomics, founded in 2000 in Barcelona, Spain, is a clinical-stage biopharmaceutical company specializing in epigenetics, particularly in 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] - Oryzon is also developing other pipeline assets targeting various epigenetic mechanisms, including ORY-4001 for CMT and ALS [5] Product Details - Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor that has shown potential in reducing cognitive impairment and neuroinflammation [6] - Preclinical studies indicate vafidemstat can restore memory and reduce aggressive behavior in models of Alzheimer's disease [6] - The drug has demonstrated efficacy in several Phase IIa trials for various psychiatric disorders and is currently being evaluated in a Phase IIb trial for schizophrenia [6][4]