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

Oxurion NV Business Update – Q3 2019

18 Oct 2019

Highlights

Pipeline

  • Positive data from Phase 1 study evaluating THR-149 (Plasma Kallikrein Inhibitor) for the treatment of DME were presented at major Retinal Conferences
    • THR-149 is well-tolerated and safe with no dose-limiting toxicities or drug-related serious adverse events reported
    • Rapid onset of action starting at Day 1 with increasing average improvement in Best Corrected Visual Acuity (BCVA) of up to 7.5 letters at Day 14 following a single injection of THR-149
    • Activity maintained up to 6.4 letters improvement at Day 90 following a single injection of THR-149
  • Patient enrolment completed in Phase 1 safety study evaluating THR-687 (pan RGD integrin antagonist) for the treatment of DME
    • Data read out anticipated around year end of 2019

Financial

  • Oxurion had cash, cash equivalents & investments of €60.5 million at the end of September 2019. This compares to €67.6 million at the end of June 2019.

 

Leuven, Belgium, October 18, 2019 – 7.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing innovative treatments to preserve vision in patients with diabetic eye disease, today issues its business and financial update for the nine month period ending September 30, 2019.

Oxurion is continuing to progress the development of its innovative pipeline of drug candidates for diabetic eye disease, particularly Diabetic Macular Edema (DME). 

The Oxurion clinical development pipeline consists of novel products with different mostly VEGF independent modes of action, which, together potentially give the Company access to a significant share of the large and fast-growing diabetic eye disease market.

Oxurion’s clinical pipeline comprises of:

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  • a potent plasma kallikrein inhibitor (THR-149) which completed a Phase 1 multicenter, dose escalation study for the treatment of DME.  Positive data showed that THR-149 is well-tolerated and safe with no dose-limiting toxicities or drug-related serious adverse events reported. The data also showed very promising efficacy results in relation to BVCA.
  • a small molecule pan-RGD integrin antagonist (THR-687) being developed to treat a broad range of patients with diabetic eye disease. Phase 1 study with THR-687 completed patient enrolment in September 2019. Topline results from the Phase 1 study are expected around year end of 2019.
  • a human placental growth factor (PlGF) neutralizing monoclonal antibody (THR-317). Following 2018 reported positive topline data from a Phase 1 study evaluating THR-317 for DME in monotherapy, Oxurion recently reported mixed topline results from an exploratory Phase 2a study THR-317 in combination with ranibizumab (Lucentis®) for DME.   

Oxurion is also evaluating THR-317 in a small Phase 2a study in Idiopathic Macular Telangiectasia Type 1 (MacTel 1). Topline data from this study are expected for early 2020. At that moment, Oxurion will announce its final overall development plans with THR-317.