ORYZON to Present Preliminary Blinded Aggregate Safety Data

• At the ten^th European Conference on Mental Health (ECMH)
• Company expects to carry out an interim evaluation in 1Q23

MADRID, Spain and BOSTON, Sept. 16, 2022 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical firm leveraging epigenetics to develop therapies in illnesses with robust unmet medical want, immediately presents preliminary preliminary blinded combination security information from its ongoing Phase IIb PORTICO trial, investigating vafidemstat in Borderline Personality Disorder (BDP), in a oral communication on the tenth European Conference on Mental Health (ECMH), being held in Lisbon (Portugal) on September 13-16.

Blinded combination security information offered at ECMH correspond to the preliminary randomized 43 sufferers (information cut-off, 30 June 2022). There had been no reported critical adversarial occasions. Forty one (41) adversarial reactions, affecting 12 sufferers handled both with vafidemstat or placebo had been reported, most of them delicate and none reported as extreme, with none main to therapy discontinuation or affected person withdrawal. In July 2022, the unbiased Data Monitoring Committee for PORTICO reviewed the obtainable security information and decided that the trial ought to proceed. PORTICO security information is aligned with aggregated security information collected from 7 accomplished vafidemstat medical trials, wherein greater than 300 topics have been handled with the drug. Current information of PORTICO proceed to assist that vafidemstat is secure and well-tolerated. An unbiased interim evaluation to assess the sign measurement and futility is anticipated to be performed in 1Q23 with the info of the primary 90 sufferers that may have concluded at the very least 2/3 of the trial.

Dr. Douglas Faller, Oryzon’s Global CMO, said: “Oryzon welcomes the opportunity to update the scientific community on our PORTICO trial of vafidemstat, an epigenetic pharmaceutical, in patients suffering from BPD. The results of the interim safety analysis are very encouraging, and support our program to develop a novel, effective and safe treatment for these underserved individuals.” Dr Michael Ropacki, Oryzon’s CNS CMO remarked: “With no approved treatments and a high rate of self-harming and suicidal behavior, BPD remains a high unmet medical need. I am extremely pleased that vafidemstat has continued to be safe and well-tolerated in the Phase IIb PORTICO clinical trial to-date. The aggregate of safety data across 9 completed and ongoing vafidemstat clinical trials has been consistent in the safety profile of this novel epigenetic LSD1 inhibitor for the treatment of psychiatric diseases.”

PORTICO (EudraCT No.: 2020-003469-20, MedicalTrials.gov Identifier NCT04932291) is a multicenter, double-blind, randomized, placebo-controlled, Phase IIb trial to consider the efficacy and security of vafidemstat in grownup BPD sufferers. The trial has two major unbiased goals: to scale back agitation and aggression and an general enchancment of BPD. The trial is presently actively recruiting sufferers in Europe and within the US, and goals to embody about 160 sufferers distributed between two arms. PORTICO has an adaptive design with a pre-defined interim evaluation to alter the pattern measurement in case of extreme variability across the endpoints.

Oryzon’s oral communication at ECMH is entitled “PORTICO, a double-blind, randomized placebo-controlled, adaptive Phase IIb trial with vafidemstat in Borderline Personality Disorder”. A replica of the presentation is obtainable right here.

For extra details about ECMH-2022, please go to ECMH’s web site.

About Oryzon
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a medical stage biopharmaceutical firm thought-about because the European chief in epigenetics. Oryzon has one of many strongest portfolios within the area, with two LSD1 inhibitors, iadademstat and vafidemstat, in Phase II medical trials, and different pipeline belongings directed towards different epigenetic targets. In addition, Oryzon has a robust platform for biomarker identification and goal validation for a wide range of malignant and neurological illnesses. For extra data, go to www.oryzon.com.

About Vafidemstat
Vafidemstat (ORY-2001) is an oral, CNS optimized LSD1 inhibitor. The molecule acts on a number of ranges: it reduces cognitive impairment, together with reminiscence loss and neuroinflammation, and on the identical time has neuroprotective results. In animal research vafidemstat not solely restores reminiscence however reduces the exacerbated aggressiveness of SAMP8 mice, a mannequin for accelerated getting older and Alzheimer’s illness (AD), to regular ranges and likewise reduces social avoidance and enhances sociability in murine fashions. In addition, vafidemstat reveals quick, robust and sturdy efficacy in a number of preclinical fashions of a number of sclerosis (MS). Oryzon has carried out two Phase IIa medical trials in aggressiveness in sufferers with totally different psychiatric issues (REIMAGINE) and in aggressive/agitated sufferers with reasonable or extreme AD (REIMAGINE-AD), with constructive medical outcomes reported in each. Additional finalized Phase IIa medical trials with vafidemstat embody the ETHERAL trial in sufferers with Mild to Moderate AD, the place a major discount of the inflammatory biomarker YKL40 has been noticed after 6 and 12 months of therapy, and the pilot, small scale SATEEN trial in Relapse-Remitting and Secondary Progressive MS, the place anti-inflammatory exercise has additionally been noticed. Vafidemstat has additionally been examined in a Phase II in extreme Covid-19 sufferers (ESCAPE) assessing the aptitude of the drug to stop ARDS, probably the most extreme issues of the viral an infection, the place it confirmed vital anti-inflammatory results in extreme Covid-19 sufferers. Currently, vafidemstat is in two Phase IIb trials in borderline persona dysfunction (PORTICO) and in schizophrenia sufferers (EVOLUTION). The firm can also be deploying a CNS precision drugs method with vafidemstat in genetically-defined affected person subpopulations of sure CNS issues and is making ready a medical trial in Kabuki Syndrome sufferers. The firm can also be exploring the medical improvement of vafidemstat in different neurodevelopmental syndromes.

FORWARD-LOOKING STATEMENTS
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