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OXURION Confirms Institutional Review Board Approval and Submission of the Investigational New Drug Application to the FDA to Start Phase 2 Study Evaluating THR-687 for Diabetic Macular Edema (DME)
Leuven, BE, Boston, MA, US – June 10, 2021 – 07.00 AM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard-of-care ophthalmic therapies, with a clinical stage portfolio in vascular retinal disorders, announces that it has received Institutional Review Board (IRB) approval to initiate a Phase 2 clinical study of THR-687 in patients with Diabetic Macular Edema (study name “INTEGRAL”). Together with its earlier submission to the U.S. Food and Drug Administration (FDA) of the final protocol to the Investigational New Drug (IND) Application, this is an important step forward for the Phase 2 INTEGRAL study.
Tom Graney, CFA, Chief Executive Officer of Oxurion, comments: “Together with our earlier submission to the FDA of the final protocol to the IND, IRB approval for the THR-687 Phase 2 trial in DME is an important milestone for OXURION. This follows the completion of enrolment of Part A in our Phase 2 program evaluating THR-149 in DME as we announced earlier this week. The team is now ready to also start this second Phase 2 program, and we are looking forward to working alongside a large team of enthusiastic investigators across the US and Europe, together creating new paths towards improved therapies for treatment of DME, a very important area of unmet medical need in diabetic eye disease.”
Today’s announcement follows the positive data reported from a Phase 1, open-label, multi-center (US), single dose escalation study (n=12) evaluating 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.
A single injection of THR-687 was reported safe and well-tolerated, showing a very encouraging efficacy signal. 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.
A clear dose response was seen with the greatest positive effect on BCVA and Central Subfield Thickness (CST) with the highest dose of THR-687. For this highest dose, a mean BCVA Improvement of 11 letters was noted at Day 14, with a peak improvement of 12.5 letters at Month 3. Similarly, a peak mean CST decrease of 106 µm was observed at Day 14 with the highest dose of THR-687.
Beyond DME, THR-687 also has development possibilities in additional vascular retinal disorders including for wet Age-related Macular Degeneration (wet AMD) and retinal vein occlusion (RVO), thereby potentially allowing the Company to tap into a broader therapeutic market with a current combined estimated annual value of $12+ billion.