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, MA, UNITED STATES, July 6th, 2020 - 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 28th 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-capital), 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.
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. Oryzon has one of the strongest portfolios in the field. Oryzon’s LSD1 program has rendered two compounds, vafidemstat and iadademstat, in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurological diseases. Oryzon has offices in Spain and the United States. For more information, visit www.oryzon.com
Vafidemstat (ORY-2001) is an oral, CNS optimized LSD1 inhibitor SNC (see Modulation of KDM1A with vafidemstat rescues memory deficit and behavioral alterations. Maes T, et al. PLOS ONE, 2020, doi: 10.1371/journal.pone.0233468.). The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed a Phase IIa clinical trial in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive preliminary clinical results reported. Additional Phase IIa clinical trials with vafidemstat are ongoing in patients with Mild to Moderate AD (ETHERAL), where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 months of treatment, and in Relapse-Remitting and Secondary Progressive MS (SATEEN).
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