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Oxurion nv Enrolls First Patient in Phase 1 Clinical Trial Evaluating THR-687, a Novel Pan-RGD Integrin Antagonist, for Treatment of Diabetic Macular Edema (DME)
Leuven, Belgium, 20 September 2018 - Oxurion NV (Euronext Brussels: OXUR - formerly known as ThromboGenics), a biopharmaceutical company developing innovative treatments to preserve vision in patients with diseases affecting the back of the eye, announced today the enrollment of the first patient in a Phase 1 open-label, multicenter, dose escalation study evaluating the safety of a single intravitreal injection of THR-687 for the treatment of patients with diabetic macula edema (DME).
THR-687 is a novel pan-RGD integrin antagonist currently being developed as a potential treatment for patients with diabetic eye disease. Preclinical studies have demonstrated THR-687's role in targeting multiple aspects of retinal vascular disease such as vessel leakage, inflammation, and neovascularization.
This Phase 1 study (THR-687-001 - NCT03666923) will primarily assess the safety of a single intravitreal injection of escalating dose levels of THR-687 in patients with DME. A maximum of 18 patients will be enrolled.
Patrik De Haes, MD, CEO of Oxurion nv, commented: "We are very excited about the progress we have made in advancing THR-687 (pan-RGD integrin antagonist) into the clinic. This is an important step in the clinical development of THR-687 and in establishing the safety profile of this pan integrin antagonist in patients with DME.
This trial initiation follows the recent start of the Phase 1 clinical trial with THR-149 (PKal inhibitor), and the initiation of a Phase 2 with THR-317 (anti-PlGF) in combination with ranibizumab (Lucentis®) in April, both for patients with DME. Our portfolio of comprehensive drug candidates addresses the clear unmet medical need for improved treatment options for this fast-growing diabetic eye disease market."
For further information please contact:
| Oxurion NV|
Global Head of Corp Coms & Investor relations
Tel: +32 16 75 13 10 / +32 478 33 56 32
| EU - Citigate Dewe Rogerson |
David Dible/ Sylvie Berrebi
Tel: +44 20 7638 9571
| US - LifeSci Public Relations |
Tel: +1 646-876-4932
Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing treatments to preserve vision in patients with diseases affecting the back of the eye. The company has built a diverse portfolio of disease-modifying therapies, including treatments for diabetic eye disease, a leading cause of blindness in people of working age worldwide.
Oxurion's clinical pipeline consists of THR-317, a PlGF inhibitor, for the treatment of diabetic macular edema (DME); THR-149, a plasma kallikrein inhibitor for the treatment of DME; and THR-687, a pan-RGD integrin antagonist for the treatment of diabetic retinopathy and DME. Further new drug candidates are currently being assessed and developed for the treatment of diabetic eye disease.
Oxurion owns the global rights to JETREA® (ocriplasmin), the only pharmacological vitreolysis drug approved for the treatment of symptomatic vitreomacular adhesion (in the U.S.) and vitreomacular traction (outside the U.S.).
Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR. In the US, Oxurion NV operates ThromboGenics inc. as a subsidiary company. More information is available at www.oxurion.com
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company's Annual Report. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of Oxurion in any jurisdiction. No securities of Oxurion may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. state securities laws.