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Oxurion Enrolls First Patient in Phase 2 Clinical Study Evaluating THR-317 (anti-PlGF) for treatment of Idiopathic Macular Telangiectasia Type 1 (MacTel 1)
Leuven, Belgium, 20 September 2018 - Oxurion NV (Euronext Brussels: OXUR), a biopharma company (formerly known as ThromboGenics) focused on developing treatments for back of the eye diseases with an innovative pipeline in diabetic eye disease, announces that it has enrolled the first patient in a Phase 2 open-label multi-centre study evaluating the efficacy and safety of intravitreal THR-317, an anti-PIGF (human placental growth factor) antibody, for the treatment of Macular Telangiectasia Type 1 (MacTel 1)
MacTel 1 is a rare disease that affects the macula and can lead to vision loss. There is currently no cure or effective treatment for MacTel 1.
This Phase 2 study (THR-317-003 - NCT03669393) plans to enrol 10 patients with macular edema caused by MacTel 1, who will each receive 3 intravitreal THR-317 injections over a period of 2 months. Efficacy and safety of the therapy will be assessed via functional and anatomic endpoints.
This clinical trial is being conducted in line with the Oxurion strategy and mission to expand its focus on developing treatments for other back of the eye diseases, in addition to its novel diabetic eye disease pipeline.
Patrik De Haes, MD, Oxurion CEO, commented: "The start of this Phase 2 study is an important step as we look to expand into additional back of the eye disorders, in line with our mission to enhance vision and fight blindness, alongside our diabetic eye disease pipeline, for which multiple important milestones have been achieved over recent months. Research suggests that PIGF could have an important role to play in MacTel 1, leading us to assess the potential of our anti-PIGF candidate THR-317 in a new eye disease area."
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
About Macular Telangiectasia Type 1
Macular Telangiectasia (MacTel), or idiopathic macular telangiectasia, is a rare degenerative retinal disease with characteristic alterations of the retinal vasculature and macula degeneration. There are two distinct types of MacTel, describing distinct clinical entities: Type 1, "aneurysmal telangiectasia," and Type 2, "perifoveal telangiectasia". MacTel 1 typically affects one eye and most commonly presents in men of 40 years to 50 years of age. In MacTel 1, capillaries of the macula become dilated and aneurysms form, causing swelling, disrupting blood flow and often leading to leakage from the blood vessels. Unlike in MacTel Type 2, neovascularisation as a result of this damage does not usually occur.
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.