ORYZON Genomics Announces First Subject Dosed In Phase I Healthy Volunteer Study Evaluating Oral Epigenetic Drug ORY-2001 For Alzheimer’s Disease

BARCELONA, Spain and CAMBRIDGE, Mass., April 4, 2016 /PRNewswire/ -- Oryzon Genomics (ISIN Code: ES0167733015), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in oncology and neurodegenerative diseases, today announced that the first subject has been dosed in a Phase I, randomized, double-blind, placebo-controlled single and multiple ascending dose program study to investigate the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of its oral LSD1-MAOB dual selective inhibitor ORY-2001 in healthy subjects. The Phase I study is being conducted in Spain, pursuant to a Clinical Trial Application (CTA). With a successful study outcome, ORY-2001 is expected to proceed to a Phase II study in Alzheimer’s disease patients in 1H 2017.

ORY-2001 is a highly selective dual LSD1-MAOB inhibitor. The molecule, which focuses on cognitive decline and memory loss, has a good safety profile and therapeutic index in preclinical trials. In non-transgenic AD mouse models, long-term treatments with the drug demonstrated a marked cognitive improvement. LSD1 is an epigenetic modulator, which regulates histone methylation. Epigenetic approaches to modify the progression of various neurodegenerative diseases focus on producing changes in patterns of gene expression in neurons and also in glia cells and are of interest for the pharmaceutical industry.

Oryzon is further exploring the potential of ORY-2001 in other neurodegenerative diseases, such as Huntington’s disease, Parkinson’s disease and other dementias. Dr. Cesar Molinero, Oryzon’s Chief Medical Officer, commented: “With our clinical trials on LSD1 inhibitors, we are gaining very valuable information of the potential of Histone Demethylase inhibitors in human diseases beyond oncology and we are particularly interested in the potential of ORY-2001 in neurodegenerative and neuroinflammatory diseases”.

About Alzheimer’s disease
Alzheimer’s disease is the most common form of dementia in adults. It is estimated to affect 5.3 million Americans and over 30 million people worldwide with an average course of 8-12 years. It is projected that the disease prevalence will double over the next 20 years. Marketed products address some of the symptoms, but there are no treatments currently available. The economic cost of Alzheimer’s is expected to grow in the coming years. Projections of the direct cost of Alzheimer’s disease in adults over 65 could balloon to $1.1 trillion in 2050 (in today’s dollars) with a total of $20.8 trillion in medical costs between 2015 and 2050, according to the Alzheimer’s Association.

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 and a clinical asset already partnered with ROCHE. Oryzon’s LSD1 program is currently covered by 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 out-license the compound for late stage development and commercialization. The company has offices in Barcelona and Cambridge, Massachusetts. For more information, visit www.oryzon.com.

FORWARD-LOOKING STATEMENTS
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SOURCE Oryzon Genomics