Developing next generation treatments to preserve vision for patients with diseases affecting the back of the eye

Oxurion NV Reports Topline Month 3 Results of Phase 2a Study Evaluating THR-317 (anti-PLGF), in Combination with Ranibizumab, for DME

Regulated Information – Inside Information
20 Aug 2019
  • Combination therapy did not show increase in BCVA in the overall population at Month 3.
  • Certain improvement in mean BCVA at Month 3 observed with the combination therapy in 2 pre-specified subgroups:
    • poor (or non) responders to prior anti-VEGF
    • patients with poor vision - baseline BCVA ≤65 letters
  • Topline data confirm THR-317 in combination with ranibizumab is safe and well-tolerated

Leuven, Belgium , 20 August 2019 – 07.30 AM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing innovative treatments to preserve vision in patients with diabetic eye disease, today reports topline data from a Phase 2a study evaluating THR-317, a humanized antibody against placental growth factor (PlGF), in combination with anti-VEGF (ranibizumab), an anti-vascular endothelial growth factor (VEGF) antibody, for the treatment of Diabetic Macular Edema (DME).

The Phase 2a randomized, single-masked, active-controlled, multicenter study evaluated the safety and efficacy of 3 monthly intravitreal injections of THR-317 and ranibizumab in subjects with center-involved DME. The combination of ranibizumab and sham was used as a control. A total of 70 patients were enrolled in the study (NCT03499223).

In this exploratory proof of concept study, the efficacy of the combination therapy in terms of the patient’s Best Corrected Visual Acuity (BCVA) was assessed as primary endpoint.

At Month 3, no improvement was observed in mean BCVA with the combination therapy when compared to ranibizumab monotherapy in the overall population. As measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) standardized eye chart, the combination therapy achieved an increase of 8.71 Letters versus an increase of 8.18 Letters for the monotherapy arm.

  • The combination therapy did show a certain improvement at Month 3 in mean BCVA in two pre-specified patient sub-groups:
  • In patients with poor (or no) response to prior anti-VEGF, a mean increase of 8.08 Letters was observed for the combination therapy vs 6.43 Letters increase for ranibizumab monotherapy
  • In patients with Baseline BCVA ≤65 letters a mean increase of 11.14 Letters was observed for the combination therapy vs 8.88 Letters increase for ranibizumab monotherapy

Topline data from the Phase 2 study show that THR-317 in combination with ranibizumab, is safe and well tolerated. No drug-related ocular serious adverse events were reported in the study.

Patrik De Haes, M.D., CEO of Oxurion, says: “The topline results from this exploratory Phase 2 study indicate that THR-317 in combination with ranibizumab could play a role in the treatment of poor (or no) response to prior anti-VEGF and with patients with a baseline BCVA of less or equal to 65 letters. We will continue to review and analyze these data before deciding on how to best position this program as we progress our clinical-stage portfolio of next-generation therapies for the treatment of DME.”

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