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

BARCELONA, Spain and CAMBRIDGE, Mass., Feb. 01, 2016 -- Oryzon Genomics (ISIN Code: ES0167733015), a clinical stage biopharmaceutical company leveraging epigenetics to develop therapies in oncology and neurodegenerative diseases, announced today 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 university 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 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.

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 families and has rendered 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 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
This communication contains forward-looking information and statements about Oryzon Genomics, S.A., including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates” and similar expressions.

Although Oryzon Genomics, S.A. believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon Genomics, S.A. shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon Genomics, S.A., that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon Genomics, S.A. to the Comisión Nacional del Mercado de Valores, which are accessible to the public.

Forward-looking statements are not guarantees of future performance. The auditors of Oryzon Genomics, S.A, have not reviewed them. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon Genomics, S.A. or any of its members, directors, officers, employees or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon Genomics, S.A. on the date hereof. Except as required by applicable law, Oryzon Genomics, S.A. does not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

US Contact:
The Ruth Group
Lee Roth/Tram Bui
(646) 536-7012/7035
[email protected]
[email protected]

Spain:
ATREVIA
Ana Melgar/Patricia Cobo
+34 91 564 07 25
[email protected]
[email protected]

The Company:
Ms. Anna K Baran
IR Director
+44 (0) 752 1083 006
[email protected]