Oryzon Genomics - Favorable safety reported in PORTICO Phase II
Oryzon presented a positive update on vafidemstat’s ongoing Phase IIb PORTICO trial in borderline personality disorder (BPD) at the ECNP Congress. The aggregated blinded safety data, as of 23 August, demonstrated a well-tolerated safety profile for a cohort with baseline characteristics reflecting real-world demographics of a typical BPD population. This is a critical consideration for therapies to progress and be successful once commercialised. We also note a low rate of discontinuations (2%) due to treatment-emergent adverse events (TEAEs) and zero discontinuations attributed to serious TEAEs. Screen failure and dropout rates, at 37% and 21%, respectively, were also favourable compared to other agents in development for BPD, such as brexpiprazole, which had higher rates (62% and 27%). As a reminder, the primary objective of the PORTICO trial is efficacy of vafidemstat, and we anticipate top-line data in Q124. Although the shared data was blinded, the overall results suggest a favourable safety profile for vafidemstat and we await next year’s efficacy readout as (if positive) it will be a key catalyst and potentially increase the probability of success for vafidemstat in BPD.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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