ORYZON Presents Final Data From its Phase IIa Clinical Trial REIMAGINE at the 28th European Congress of Psychiatry, EPA 2020

• Vafidemstat reduces aggression in the three psychiatric disorders studied
  
• Patients with Borderline Personality Disorder show a more relevant improvement
• The company will shortly start a Phase IIb trial in this indication

MADRID, Spain and CAMBRIDGE, Mass., July 06, 2020 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, has presented the final data from its Phase IIa clinical trial REIMAGINE at the 28^th European Congress of Psychiatry, EPA 2020, which is being held on July 4-7.

Oryzon presented an e-Poster entitled “Vafidemstat reduces aggressiveness in three different psychiatric disorders. Final data from the REIMAGINE trial". The data presented are the final data of the 30 patients who participated in the study: 12 patients with Borderline Personality Disorder (BPD), 11 with ADHD and 7 with Autism Spectrum Syndrome (ASD), and confirm the preliminary data that the company had previously presented at various conferences during 2019. The efficacy of vafidemstat in the control of agitation and aggression was assessed using various validated scales (CGI-S, CGI-I, NPI-A/A) while the global improvements observed in the patients were assessed using another set of scales (Total NPI, BPDCL, C-SSRS, ADHD-RS). A correlation has been observed between the various clinical improvements caused by the drug. The most significant improvements were found in the BPD population, where a remarkable overall improvement was also observed as measured by BPDCL. To view the poster, you can check its electronic version here. The company plans to publish these data in an expanded form in a peer-reviewed international medical journal.

With the progressive normalization of the health situation in Europe and after the successful fund raise carried out at the end of June, which significantly strengthens the financial capacity of the Company (see https://www.oryzon.com/en/news-events/news/oryzon-raises-its-share-cap ...), Oryzon plans to submit in the coming weeks a Clinical Trial Application (CTA), the European IND equivalent, to the Spanish Drug Agency (AEMPS) to perform a Phase IIb clinical trial to evaluate vafidemstat for the treatment of agitation and aggressiveness in patients with Borderline Personality Disorder. This will be a double-blind, placebo-controlled, multicenter trial and will include a number of patients compatible with the possibility of obtaining a statistically significant efficacy signal. This trial, named PORTICO, will start in Spain to progressively deploy to other European countries and the USA.