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MADRID, SPAIN and CAMBRIDGE, MA--(Marketwired - November 13, 2017) -
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, has presented today new preclinical data on its investigational drug ORY-2001, a selective LSD1-MAOB dual inhibitor, at the SfN's 47th
annual meeting (Neuroscience 2017), being held at the Walter E. Washington Convention Center, Washington DC (USA) in November 11-15. The communication, presented as Poster no. 336.09 at the "Cortical Systems and Mechanisms of Disease" Session and entitled "ORY-2001, a dual LSD1/MAOB inhibitor in development for neurodegenerative diseases, normalizes aggressive behavior in SAMP-8 mice and social avoidance in isolated rats" was presented by neuroscientists from the company accompanied by the Medical Director, Dr. Roger Bullock.
The company had previously reported that ORY-2001 completely rescues the profound memory deficit of SAMP8 mice, a model of sporadic Alzheimer's disease (AD) that undergoes an accelerated aging, and that even in delayed start experiments the drug is able to restore memory in these animals. Different experiments suggest that ORY-2001 acts as a disease modifying drug. In AD patients and other neurodegenerative disorders, cognitive deterioration is often accompanied by episodes of agitation, aggression, psychosis, apathy and depression. The preclinical data presented demonstrate that the epigenetic drug ORY-2001 reduces the exacerbated aggressiveness of SAMP8 mice to normal levels and also reduces social avoidance in rat models maintained in isolation.
In a Phase I clinical trial conducted with 106 healthy volunteers ORY-2001 demonstrated safety and tolerability, and allowed to establish the doses for a phase II in patients. It was also determined that it penetrates the brain with high efficiency. The company recently received the approval of the Spanish Agency of Medicines (AEMPS) to carry out a Phase IIA with ORY-2001 in patients with multiple sclerosis. The company plans to request soon the corresponding authorizations for a Phase IIA clinical trial in patients with Alzheimer's disease.
The President and CEO of the company, Dr Carlos Buesa stated that "These results provide new evidence in an already long chain of positive results generated in seven different animal models that strongly reinforce the proposal of an epigenetic treatment in neurodegenerative diseases. The company is firmly committed to trying to help patients with our novel drugs. The recent start of a Phase IIA in patients with multiple sclerosis opens a new stage for the company."
The Medical Director of Oryzon, Dr. Roger Bullock, a well-known international specialist in the field, commented: "These data are really very interesting. This drug efficiently reaches the brain where it improves, even restores memory and reduces inflammation. In addition, we now see that it affects the psychiatric and behavioral alterations that are often associated with Alzheimer's disease patients. This reduction of agitation, aggression and social avoidance in the animal models showcases ORY-2001 as capable of acting in all the processes that manifest in AD patients."
The Society for Neuroscience (SfN) 47th
annual meeting, Neuroscience 2017, is the world largest conference in Neuroscience.
ORY-2001 is a highly selective dual inhibitor of LSD1-MAOB. The molecule acts on several levels, reduces cognitive impairment, memory loss and neuroinflammation, and at the same time has neuroprotective effects. In several preclinical models of MS, ORY-2001 exhibits strong and durable efficacy. 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.
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.
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. This press release is not an offer of securities for sale in the United States. The Company's securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of the Company's securities to be made in the United States will be made by means of a prospectus that may be obtained from the Company or the selling security holder, as applicable, that will contain detailed information about the Company and management, as well as financial statements.
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