Oryzon Genomics - PORTICO update with planned FDA EoP2
Oryzon Genomics has announced top-line results for the Phase IIb trial (PORTICO) assessing vafidemstat in borderline personality disorder (BPD), and while the primary endpoints (Borderline Personality Disorder Checklist (BPDCL) and Clinical Global Impression – Severity Agitation/ Aggression (CGI-S A/A)) did not reach statistical significance, vafidemstat was favoured over placebo in all efficacy measures, with nominal statistical significance in two key secondary endpoints (Borderline Evaluation of Severity (BEST) and State-Trait Anger Expression Inventory 2 (STAXI-2) Trait Anger). Further, the drug was found to be safe and well-tolerated, consistent with prior studies. Management plans to conduct a detailed analysis of the trial data across the coming months and intends to request an end-of-Phase II (EoP2) meeting with the FDA in early Q224 to discuss a potential registrational Phase III programme. There are currently no approved drugs for this indication and hence gold-standard endpoints are yet to be established. We therefore believe that there is still a significant opportunity for Oryzon in this space, however, further clinical progression will be heavily reliant on the EoP2 meeting request and outcome.Oryzon Genomics SA is a Spain-based biopharmaceutical company. It is engaged in the field of epigenetic medicine and in the development of therapeutic, biological solutions for cancer and neurodegenerative diseases. The Company's business model focuses on identifying biomarkers that can be translated in new therapeutic targets, as well as on investing in programs, mainly through the development of small molecules for two main indications: cancer and neurodegeneration. The Company develops investigational medicines till proof of concept (POC) phase and then partners the program with pharmaceutical entities, which are able to get the approval from drug agencies to bring these medicines to the patients. It cooperates with Roche. The Company is a subsidiary of Laboratorio Reig Jofre SA.
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