Oryzon Receives Approval in Spain to Initiate Phase I for ORY-2001 for Alzheimer’s Disease

Oryzon Genomics (ISIN Code: ES0167733015), a clinical stage biopharmaceutical company leveraging epigenetics to develop therapies in oncology and neurodegenerative diseases, announced that the Company received approval of its Clinical Trial Application from the Spanish Drug Agency (AEMPS) to initiate a Phase I clinical trial for ORY-2001 for the treatment of Alzheimer's disease.

The Phase I trial will be conducted at a reputed Phase I clinical trial unit of a universit y hospital in Barcelona, Spain. The trial will evaluate the safety, tolerability and pharmacokinetics of ORY - 2001 in healthy subjects as well as the elderly population. In addition to the treatment of Alzheimer's disease, ORY - 2001 is in preclinical development to assess the potential effectiveness in other neurodegenerative diseases.

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 precl inical 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.

Dr. César Molinero, Oryzon’s Chief Medical Officer , commented, " We are excited to continue to advance our pipeline in the field of epigenetics. With the approval of our Clinical Trial Application in Spain , ORY - 2001 is Oryzon’s second molecule that will move to clinical development . 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. Alzheimer’s is the most common form of dementia affecting more than 30 million people globally and we are thrilled with the prospect to potentially treat this disease .”

About Oryzon

Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) , is a clinical stage biopharmaceutical company considered 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 19 patent famili es and has ren d ered one compound in clinical trials and another one is anticipated to enter clinical trials in early 2016. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. The company has a strong technol ogical 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