Oxurion NV to Focus Clinical Development on Molecules Targeting VEGF Independent Pathways for Treatment of DME

Oxurion NV to Focus Clinical Development on Molecules Targeting VEGF Independent Pathways for Treatment of DME

• Pipeline to focus on clinical development of THR-149 and THR-687
   
• No further investment in the clinical development of THR-317
   
• Commercialization of JETREA to be shifted to distributors/ licensees in marketed territories, patient access to be maintained 

Leuven, Belgium, 19 December 2019 – 17:45 CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing innovative back of the eye treatments to preserve vision in patients with diabetic eye disease, announces it is to focus its activities on the clinical development of THR-149 and THR-687 as potential VEGF independent treatments for Diabetic Macular Edema (DME). THR-149 is a novel potent plasma kallikrein inhibitor while THR-687 is a Pan-RGD integrin inhibitor, both of which have the potential to treat a broad range of patients with diabetic eye disease.

Oxurion’s clinical pipeline now comprises:

• THR-149, which has shown positive topline Phase 1 results for the treatment of DME. The Company plans to conduct a Phase 2 clinical program, which is expected to start in H1 2020.

• THR-687, which is in a Phase 1 clinical study assessing it as a treatment for DME. Results from this study are expected in early 2020.

Patrik De Haes, M.D., CEO of Oxurion, said: “We believe that with THR-149 and THR-687 we have the opportunity to become a global leader in providing retina physicians with novel VEGF independent treatment options for patients with DME. There is clear need for novel medicines that act via VEGF independent pathways, to address many of the limitations of the VEGF inhibitors, the current standard of care for DME. It is estimated that 40% of DME patients treated with anti-VEGF do not, or sub optimally respond to anti-VEGF treatment.

Given the attractiveness of the VEGF independent opportunity, and our confidence in our novel compounds’ ability to address this clear unmet medical need, we have decided to make no further investment in the development of THR-317. This reflects the competitive nature of the VEGF market and the mixed Phase 2 results with THR-317 which we released in August 2019. Results from the on-going Mactel-1 study with THR-317 are expected to be presented at a scientific conference in 2020.

The decisions we have announced today will simplify our organizational structure, allowing us to focus our resources on what we believe are two of the most exciting potential new therapies for diabetic eye disease currently in the clinic.”

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About Oxurion

Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing a pipeline of novel clinical drug candidates acting on VEGF-independent pathways for the treatment of diabetic eye disease, a leading cause of blindness in people of working age worldwide.

Oxurion’s clinical pipeline comprises:

• THR-149, a plasma kallikrein inhibitor, that has shown positive topline Phase 1 results for the treatment of DME. The Company is currently preparing to conduct a Phase 2 clinical program, which is expected to start in H1 2020. THR-149 was developed in conjunction with Bicycle Therapeutics

• THR-687, a pan-RGD integrin inhibitor, that is in a Phase 1 clinical study assessing it as a treatment for DME. Results from this study are expected in early 2020. THR-687 is an optimized compound derived from a broader library of integrin inhibitors in-licensed from Galapagos.

Oxurion is headquartered in Leuven, Belgium, and is listed on the Euronext Brussels exchange under the symbol OXUR. 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 law