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ORYZON Announces Enrollment of First Patient in ESCAPE: a Phase II Clinical Trial with Vafidemstat in Severely Ill COVID-19 Patients
[May 18, 2020]

ORYZON Announces Enrollment of First Patient in ESCAPE: a Phase II Clinical Trial with Vafidemstat in Severely Ill COVID-19 Patients


MADRID, Spain and CAMBRIDGE, Mass., May 18, 2020 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today the enrollment of the first patient in its Phase II clinical trial with vafidemstat in seriously ill COVID-19 patients.

The study, named ESCAPE (Nº EudraCT: 2020-001618-39), is an open-label, randomized, double arm Phase II trial to assess the efficacy and tolerability of vafidemstat in combination with standard of care, to prevent progression to Acute Respiratory Distress Syndrome (ARDS). The study has two treatment arms: in one the patients will receive standard of care and in the other the standard of care in combination with vafidemstat. Each of the study arms will include 20 patients. The endpoints of the study will be assessed at days 5, 14 and 28.

If positive clinical signs are identified, additional centers and patients may be added. Given the current epidemiological dynamics of the pandemic in Spain and elsewhere in Europe, the company expects to be able to report initial efficacy data before the end of the year.

Carlos Buesa, President and CEO of Oryzon, said: “We at Oryzon are very proud to be playing our part in the fight against COVID-19 with this study. While our business remains focused on epigenetics, it is essential to do everything we can to address the greatest threat to public health of our times.”

ESCAPE (Efficacy and Safety of a Combined treatment with vafidemstat to prevent ARDS in adult Patients with severE COVID-19) (EudraCT No.: 2020-001618-39) aims to explore a therapeutic intervention to prevent progression of severely ill COVID-19 patients with pneumonia to ARDS, one of the main causes of death in this disease, by reducing the patient’s inflammatory response to the infection. For more details, please visit  https://www.oryzon.com/sites/default/files/PRESS_RELEASE_10-2020.pdf

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. Oryzon has one of the strongest portfolios in the field. Oryzon’s LSD1 program has rendered two compounds, vafidemstat and iadademstat, in clinical trials. In addition, Oryzon has ongoing programs for developing inhibitors against other epigenetic targets. Oryzon has a strong technological platform for biomarker identification and performs biomarker and target validation for a variety of malignant andneurological diseases. Oryzon has offices in Spain and the United States. For more information, visit www.oryzon.com



About Vafidemstat
Vafidemstat (ORY-2001) is an oral, CNS optimized LSD1 inhibitor. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed a Phase IIa clinical trial in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive preliminary clinical results reported. Additional Phase IIa clinical trials with vafidemstat are ongoing in patients with Mild to Moderate AD (ETHERAL), where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 months of treatment, and in Relapse-Remitting and Secondary Progressive MS (SATEEN).

FORWARD-LOOKING STATEMENTS
This communication contains, or may contain, forward-looking information and statements about Oryzon, 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 believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon 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 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 to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. 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 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 on the date hereof. Except as required by applicable law, Oryzon 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 or any other jurisdiction. Oryzon’s securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon’s securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.


IR & Media, US & Europe:Spain:Oryzon:
LifeSci Advisors LLC ATREVIAEmili Torrell
Hans HerklotsPatricia Cobo/Carlos C. UngríaBD Director
+41 79 598 7149+34 91 564 07 25+34 93 515 13 13
hherklots@lifesciadvisors.compcobo@atrevia.com
cungria@atrevia.com
etorrell@oryzon.com

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