SOURCE: Oryzon Genomics

Oryzon Genomics

October 31, 2017 08:31 ET

ORYZON receives approval from AEMPS to start SATEEN: a Phase IIA clinical trial in Multiple Sclerosis with ORY-2001

The company expects to start enrollment before year's end

MADRID, SPAIN and CAMBRIDGE, MA--(Marketwired - October 31, 2017) - Oryzon Genomics (MAD: ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, today announced that it has received approval of a Clinical Trial Application (CTA), the European IND equivalent, from the Spanish Drug Agency (AEMPS) to conduct a PhaseIIA clinical study with ORY-2001 in patients of Multiple Sclerosis (MS).

The study, named SATEEN (SAfety, Tolerability and Efficacy in an EPIGENETIC approach to treat Multiple Sclerosis), will be conducted in different Spanish hospitals, and is designed as a randomised, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS).

In a recent Phase I trial carried out in 106 healthy volunteers, the drug proved to be safe and well tolerated. There were no adverse events related to the drug, neither significant side effects nor clinical changes detected. Importantly, at the doses to be applied in the Phase II no hematopoietic effects were observed. Brain penetrance was measured in 18 volunteers, and target engagement with the brain LSD1 enzyme was also established separately. These results were recently reported at the AAIC Conference in London.

ORY-2001 is a highly selective dual LSD1-MAOB inhibitor. The molecule has been shown to revert cognitive decline and memory loss, to decrease neuroinflammation and has also shown neuroprotection in a variety of preclinical models of AD, MS and ALS, suggesting that it might have a disease modifying potential. In different MS models, ORY-2001 reduces lymphocyte egress and demyelination and improves the clinical score of the animals, suggesting an epigenetic axis in MS.

Roger Bullock, Oryzon's Chief Medical Officer, commented, "In line with our expectations, the approval of SATEEN, the Phase IIA clinical trial for ORY-2001 in MS, represents a significant milestone for the company. Preclinical studies validate the potential of ORY-2001 to treat cognitive defects and neuroinflammation resulting from several neurodegenerative disorders and this is the first step in validating this novel approach in people who actually have a neurodegenerative disorder, namely MS. The entry of a safe, well tolerated, orally taken compound, that offers neuroprotection and reduces neuroinflammation, could be a significant step in our ongoing quest to impact on some of the most challenging disorders of our time, including MS, Alzheimer's disease and ALS. We are very pleased to have reached this landmark position and look forward to the results."

Carlos Buesa, Oryzon's President and Chief Executive Officer, commented, "We are really excited about Oryzon starting SATEEN with ORY-2001, whose properties might represent a clinical advantage for patients with Multiple Sclerosis. We expect to be able soon to start another Phase II trial with ORY-2001 in Alzheimer's disease and we keep exploring other neurodegenerative disorders."

About Oryzon

Founded in 2000 in Barcelona, Spain, Oryzon (MAD: ORY) 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.

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. 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.

Contact Information