Oxurion NV Reports Positive Topline Data from Phase 1 study evaluating THR-687 for treatment of DME

Oxurion NV Reports Positive Topline Data from Phase 1 study evaluating THR-687 for treatment of DME
                                                        

THR-687 is a potent pan-RGD integrin antagonist in development for DME and DR
       

• Topline data show that THR-687 is well-tolerated and safe. No dose-limiting toxicities or serious adverse events reported
• Rapid onset of action and prolonged effect on Best Corrected Visual Acuity (BCVA) seen across all doses of THR-687 following a single injection  
  • Mean BCVA improvement of 3.1 letters at Day 1
  • Mean BCVA improvement of 9.2 letters at Month 1
  • Mean BCVA improvement of 8.3 letters at Month 3
• A dose response effect in BCVA and Central Subfield Thickness (CST) was shown
• Phase 2 study planned for H2 2020 with this VEGF-independent treatment option in the treatment of naïve DME patients

       
Leuven, Belgium, 7 January 2020 – 07.00 AM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing a pipeline of novel clinical drug candidates acting on VEGF-independent pathways to preserve vision in patients with diabetic eye disease, today reports positive topline data from a Phase 1 study with THR-687, a novel, potent, pan-RGD integrin antagonist for the treatment of Diabetic Macular Edema (DME).

The Phase 1, open-label, multi-center (US), single dose escalation study evaluated the safety of a single intravitreal injection of 3 increasing doses (0.4 mg, 1.0 mg, 2.5 mg) of THR-687 for the treatment of DME (NCT03666923). Patients recruited into the study had a history of response to prior anti-VEGF and/or corticosteroid treatment. At baseline, the study patient population had a mean BCVA of 56 letters, and a mean Central Subfield Thickness (CST) of 542µm.

Topline data from the trial show that THR-687 is well-tolerated and safe with no dose-limiting toxicities. No serious adverse events were reported at any of the doses evaluated in the study.

The study also looked at efficacy including changes to the patient’s BCVA. Across all doses, a rapid onset of action in mean BCVA was observed from Day 1 with an increase of 3.1 letters, which further improved to 9.2 letters at Month 1. This activity was maintained with a mean BCVA improvement of 8.3 letters at Month 3 following a single injection of THR-687.