BARCELONA, SPAIN and CAMBRIDGE, MA--(Marketwired - January 25, 2017) - Oryzon Genomics (MAD: ORY) (ISIN Code: ES0167733015), a public clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that it will present preliminary top-line clinical results from the first-in-man clinical trial to assess safety, tolerability and pharmacokinetics of ORY-2001, a novel epigenetic drug for treatment of neurodegenerative diseases, at the 13th ADPD International Conference to be held in Vienna, Austria from March 29th to April 2nd.
Preliminary data on safety, pharmacokinetics, target engagement and surrogate biomarker in peripheral samples in the SAD and MAD phases in 88 healthy volunteers administered with different doses of ORY-2001 will be presented by Dr. César Molinero, Medical and Clinical Operations Director of the Company on March 31st on the symposium 38 - short oral session 03 - short oral presentations of selected posters - that starts at 17.15 PM CET.
With a successful study outcome, ORY-2001 is expected to proceed to a Phase II study in Alzheimer's disease patients in 2H 2017. "We are pleased to present this first in human clinical data that will hopefully pave further development of ORY-2001," said Dr. César Molinero, CMO of Oryzon.
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 nontransgenic AD mouse models, long-term treatments with the drug demonstrated a marked cognitive improvement. The company has also recently presented data that supports the potential application of this experimental drug in other CNS neuroinflammatory disorders such as Multiple Sclerosis. LSD1 is an epigenetic modulator, which regulates histone methylation. 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.
Oryzon has a highly competitive and productive Epigenetics Platform, centered around the development of LSD1 inhibitors, with a first forerunner program licensed to Roche (ORY-1001/RG6016) that has recently finished Phase I/IIA in acute leukemia and is currently being explored in an ongoing Phase I clinical trial in Small Cell Lung Cancer that validates the platform scientifically and clinically. This Platform has so far produced two additional programs: ORY-2001, already in clinical development with multiple indication opportunities that is pioneering the histone demethylases field in neurodegenerative disorders; and ORY-3001, also against LSD1, currently in preclinical development for a yet undisclosed non-oncological orphan indication.
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 and a clinical asset already partnered with Roche. Oryzon's LSD1 program is currently covered by 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 Barcelona and Cambridge, Massachusetts. For more information, visit www.oryzon.com.
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