Delivering next-generation treatments for back of the eye disorders, with focus on diabetic eye disease

Oxurion NV Business Update – Q1 2019

8 May 2019

Oxurion NV Business Update – Q1 2019
Significant Progress with Novel Clinical Diabetic Eye Disease Portfolio
Enrollment of THR-317 Phase 2 Combination Study & THR-149 Phase 1 Study Completed Ahead of Schedule
First Clinical Readout Expected by Q3 2019  
Total Cash & Investments at €76.2 million on 31 March 2019

Highlights

  • Patient enrollment completed in April 2019 of a Phase 2 trial evaluating the efficacy and safety of intravitreal THR-317 (anti-PlGF) administered in combination with ranibizumab (anti-VEGF) for the treatment of diabetic macular edema (DME)

  • Patient enrollment completed in April 2019 of a Phase 1 dose escalation safety study evaluating THR-149 for the treatment of DME  

  • Results from THR-317 and THR-149 clinical studies are expected by Q3 2019

  • Two further clinical read-outs expected before end of 2019

  • Oxurion had €76.2 million in cash & investments at the end of March 2019. This compares to €85.1 million at the end of December 2018.

Leuven, Belgium, May 8, 2019 – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing innovative treatments to preserve vision in patients with diabetic eye disease, today issues a business update and a financial update for the three-months ending March 31, 2019.

Oxurion is developing a competitive pipeline of disease modifying drug candidates for diabetic eye disease, particularly DME.

The Oxurion clinical development pipeline consists of novel products with different modes of action, which, together potentially give the Company access to a significant share of the diabetic eye disease market. Oxurion’s clinical pipeline comprises of:

  • a human placental growth factor (PlGF) neutralizing monoclonal antibody (THR-317) which is in a Phase 2 study evaluating the efficacy and safety of intravitreal THR-317 when administered in combination with ranibizumab (Lucentis®), for the treatment of DME. Recruitment of this study is completed, and results are expected in early Q3 2019.

In addition, THR-317 is being evaluated in a Phase 2 study for the treatment of Idiopathic Macular Telangiectasia Type 1 (MacTel 1), a rare disease that affects the macula and can lead to vision loss. First data from this study are expected towards the end of 2019.

  • a potent plasma kallikrein inhibitor (THR-149) is in a Phase 1 multicenter, dose escalation study for the treatment of DME. Recruitment of this study has recently completed with results anticipated by early Q3 2019.

  • a small molecule pan-RGD integrin antagonist (THR-687) being developed to treat a broad range of patients with diabetic eye disease. THR-687 entered the clinic in September 2018. Results from the on-going Phase 1 study are expected towards the end of 2019.

Patrik De Haes, MD, CEO of Oxurion nv, commented: “We are making excellent progress with our competitive pipeline of disease-modifying drug candidates for diabetic eye disease, the leading cause of blindness in people of working age.   We have completed recruitment ahead of schedule of our Phase 2 study evaluating the efficacy and safety of intravitreal THR-317 when administered in combination with ranibizumab (Lucentis®), for the treatment of DME. We have also completed recruitment of our Phase I study with THR-149. Results from these studies are expected by Q3 2019. Later in the year we plan to announce the results from a Phase I study with THR-687 and a Phase 2 study with THR-317 in patients with MacTel1. We are confident that 2019 will be a milestone year for Oxurion as we continue to advance our clinical pipeline of novel disease-modifying therapies and remain confident in their potential to preserve the vision of patients with diabetic eye disease.”

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