Leuven, BELGIUM, Boston, MA, US – JUNE 13, 2022 – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard of care ophthalmic therapies, with clinical stage assets in vascular retinal disorders, today announced that two presentations were delivered at The Macula Society 45th Annual Meeting, June 8 -11, 2022 in Berlin, Germany.
TITLE: KALAHARI: Part A Results of the Phase 2 Study of THR-149, a Plasma Kallikrein Inhibitor, in Subjects with DME Responding Sub optimally to anti-VEGF Treatment
PRESENTER: Shree K. Kurup, MD, Dept. of Ophthalmology, University Hospitals, Cleveland, OH
- Multiple IVT injections (up to 3) of THR-149 (0.01, 0.04, 0.13 mg) are safe and well-tolerated
- In the high dose group:
- A mean BCVA gain of 6.1 letters was seen at Month 3, with gains observed up to Month 6 as well as CST stabilization over the 6-month study period compared to Baseline
- No need for rescue treatment
- Post-hoc analysis, excluding 2 subjects with abnormalities on OCT, showed a mean gain in BCVA of 9.3 letters at Month 3, which was maintained up to Month 6
THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the up to 50% of diabetic macular edema (DME) patients showing suboptimal response to anti-VEGF therapy. Oxurion is evaluating THR-149 for the treatment of DME in Part B, the second part of its two-part Phase 2 KALAHARI trial.
TITLE: THR-687, a Potent and Highly Selective RGD Integrin Inhibitor in Development for the Treatment of Diabetic Macular Edema
PRESENTER: Francesco Bandello, Professor and Chairman of the Department of Ophthalmology, VitaSalute, Milan, Italy
- Study population was representative of treatment naïve DME patients based on the CRC feedback on OCT at BL
- Mean BL BCVA and CST values were aligned with naïve DME studies for other compounds
- There was insufficient evidence of efficacy on the key endpoints (BCVA and CST)
- THR-687 is safe and well tolerated
- No rescue medication was administered to any of the subjects
- The ocular AEs are consistent with the progressive nature of DME, no toxic drug effects occurred
THR-687 is a highly selective pan-RGD integrin antagonist that Oxurion had been developing as a first line therapy for DME patients. Recently released data from Part A, the first part of its two-part Phase 2 INTEGRAL trial showed THR-687 to be safe and well tolerated with no serious adverse events and none of the patients requiring rescue medication through Month 3, however, there was insufficient evidence of efficacy on the key endpoints (Best-Corrected Visual Acuity and Central Subfield Thickness). As a result, Oxurion has decided not to advance THR-687 to Part B of the INTEGRAL trial.
Oxurion (Euronext Brussels: OXUR) is a biopharmaceutical company developing next generation standard of care ophthalmic therapies, which are designed to improve and better preserve vision in patients with retinal disorders including diabetic macular edema (DME), the leading cause of vision loss in working-age people, as well as other conditions. Oxurion intends to play an important role in the treatment of retinal disorders, including the successful development of THR-149, its novel therapeutic for the treatment of DME. THR-149 is a potent plasma kallikrein inhibitor being developed as a potential new standard of care for the up to 50% of DME patients showing suboptimal response to anti-VEGF therapy. Oxurion is headquartered in Leuven, Belgium, with corporate operations in Boston, MA. More information is available at www.oxurion.com.
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