ORYZON announces First Patient in ORY-2001 MS Phase IIA trial SATEEN and presents new data on ORY-2001 at the third annual ACTRIMS Forum 2018 in San Diego

MADRID, SPAIN and CAMBRIDGE, MA–(Marketwired – January 29, 2018) – Oryzon Genomics (ISIN Code: ES0167733015) (MAD: ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today the inclusion of the First Patient in the SAfety, Tolerability and Efficacy in an EPIGENETIC approach to treat Multiple Sclerosis, SATEEN, Phase IIA clinical trial with ORY-2001 in Multiple Sclerosis. The company further announced that it will present new data on ORY-2001 at the third annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018, which will take place February 1-3 at the Hilton San Diego Bayfront in San Diego, California.

On Thursday February 1st 2018 Chief Scientific Officer Dr. Tamara Maes will present the poster P063 titled “ORY-2001 reduces inflammatory cell infiltration in the Theiler’s murine encephalomyelitis virus model and highlights the epigenetic axis in MS” in Poster Session 1 at the Opening Reception, from 6-8 PM. Dr. Maes said, “In previous reports we showed that ORY-2001 reduces the clinical score, lymphocyte egress, immune cell infiltration and inflammation protecting the spinal cord from demyelination in a murine MS-EAE model. Here we provide data on the efficacy of ORY-2001 in the Theiler’s murine encephalomyelitis virus (TMEV) model for multiple sclerosis. ORY-2001 significantly reduced the clinical score, improved motor activity, reduced inflammatory cell infiltration and improved axonal integrity.”

In the same session, Dr. Roger Bullock, Chief Medical Officer of the company, will present poster P040 titled “ORY-2001 in multiple sclerosis: first clinical trial of a dual LSD-1/MAOB inhibitor“. In this communication we show that the compound is being tested in a Phase IIA clinical trial in patients with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) over a 36-week period followed by an open label extension. “This is an exciting step forward for Oryzon,” said Dr. Roger Bullock. “Our first patient enrolled in SATEEN, the first Phase IIA trial with ORY-2001, signals a new landmark for the clinical development of this drug in different neurological indications. This is the first epigenetic approach in this disease and we hope that it will contribute to enlarge and improve the therapeutic options for patients afflicted by MS.”

ACTRIMS Forum is the main US Conference for scientists and clinicians at the cutting edge of MS research. Approximately 1,000 attendees are expected in 2018 as ACTRIMS continues to further its mission of providing leadership in the field of multiple sclerosis and other demyelinating diseases.

ORY-2001 is an orally administered, brain penetrant drug that selectively inhibits LSD1 and MAOB. The molecule has been shown to reduce cognitive impairment and neuroinflammation in preclinical models, and exerts neuroprotective effects. The drug has been tested in 6 month rat and 9 month dog GLP toxicology studies to enable long term Phase II studies. The safety and tolerability of ORY-2001 has been studied in a Phase I clinical trial with 106 young and elderly healthy volunteers, confirmed LSD1 target engagement and ORY-2001 brain penetration, and allowed to establish the doses for the Phase II dose finding studies in patients. In addition to the ongoing Phase IIA study with ORY-2001 in patients with Relapse-Remitting and Secondary Progressive multiple sclerosis (MS), the company aims to obtain authorization for a Phase IIA clinical trial in patients with Alzheimer’s disease.

LSD1 is an epigenetic modulator, which regulates histone methylation and modulates gene expression patterns. Epigenetic approaches to modify the progression of various neurodegenerative diseases, which focus on the production of changes in gene expression patterns in brain cells, have generated interest in the pharmaceutical industry.

About Multiple Sclerosis

Multiple sclerosis is an autoimmune disease that is caused by recurrent inflammatory attacks on the central nervous system (CNS) due to a malfunction of the immune system, leading to neurological disability. This attack, carried out by cells of the immune system, causes loss of myelin from the oligodendrocytes. These cells coat the axons of neighboring neurons with their myelin sheets allowing rapid transmission of nerve impulses. Inflammation is the major contributor to neuromuscular degeneration associated with MS. However, the exact underlying cause of the inflammatory autoimmune process is poorly understood. MS seems to involve a complex combination of genetic susceptibility and non-genetic triggers. Data from the World Health Organization (WHO) estimate that the global prevalence is 30 cases per 100,000 inhabitants and the estimated incidence is approximately 2.5 cases per 100,000 inhabitants. Globally, MS has an average age of onset of 30 years and occurs approximately twice as often in women than in men. MS affects approximately 2.5 million people worldwide each year and is the most debilitating neurological disease in young adults. There are several forms of MS, relapse-remitting and progressive multiple sclerosis. Progressive forms are still a great unmet medical need. It is expected that the global market for MS in the US and EU5 will grow to $ 20 billion by 2024.

About Oryzon

Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company considered as the European champion in Epigenetics. The company has one of the strongest portfolios in the field. Oryzon’s LSD1 program has resulted in + 20 patent families and has rendered two compounds in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. The company has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant and neurodegenerative diseases. Oryzon’s strategy is to develop first in class compounds against novel epigenetic targets through Phase II clinical trials, at which point it is decided on a case-by-case basis to either keep the development in-house or to partner or outlicense the compound for late stage development and commercialization. The company has offices in Spain and USA. For more information, visit www.oryzon.com.


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Thomas Hoffmann
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Patricia Cobo/Luis Rejano

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The Company:
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BD Director

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