Wednesday, October 5

Oryzon rises more than 1% in the stock market after receiving authorization to start the PORTICO trial in Serbia

Oryzon Genomics, a clinical-phase biopharmaceutical company focused on epigenetics for the development of therapies in diseases with significant unmet medical needs, today announced that it has received the authorization from the Serbian Agency for Medicines and Health Products (ALIM) to conduct a Phase IIb clinical study with vafidemstat in patients with Borderline Personality Disorder (BPD) in Serbia. This clinical study is already active and recruiting patients in Spain, Germany, Bulgaria and the USA.

Following this statement announced early in the morning by the pharmaceutical company for the National Securities Market Commission (CNMV), Oryzon shares begin a new bullish day with increases of 1.24% to 2.85 euros per intraday share, recovering the value of a month ago.

The study, called PORTICO, is a Phase IIb, multicenter, double-blind, randomized, placebo-controlled trial to evaluate the Efficacy and safety of vafidemstat in adult BPD patients. The trial has two independent primary objectives: reducing patient agitation and aggressiveness, and overall improvement of the disease. The trial will be carried out at 15-20 centers in Europe and the US and is expected to recruit about 160 patients, spread over two arms. PORTICO is adaptive design with a predefined interim analysis to adjust sample size for excessive variability around endpoints or unexpectedly high placebo rate.

The Oryzon Medical Director for SNC, Dr. Michael Ropackicommented: “The start in Serbia culminates the deployment phase of PORTICO and will help accelerate its implementation. PORTICO’s protocol provides for an interim analysis after the first 90 patients have completed the study. This is expected to occur before In late 2022. Considering the role of epigenetics in psychiatric illness, and in BPD in particular, as well as previous positive data from the REIMAGINE trial in BPD patients, Oryzon believes that vafidemstat could transform the treatment of patients with BPD. TLP. “

PORTICO bases its scientific rationale on ability of vafidemstat to inhibit LSD1, reducing aggression, increasing sociability and mitigating social avoidance, as has been proven in several preclinical models as well as in clinical data obtained in the Phase IIa REIMAGINE trial, where vafidemstat reduced agitation-aggression in patients with BPD, attention deficit hyperactivity disorder and autism spectrum disorder, and showed positive overall effects in these psychiatric disorders, especially in BPD, after 2 months of treatment. Vafidemstat has shown a favorable safety and tolerability profile in multiple Phase I / II clinical trials, with more than 300 subjects treated, some of them for up to 24 months. Vafidemstat has not been associated with sedation, weight gain, or extrapyramidal side effects, which are common in current antipsychotic treatments, or with any other adverse event.

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