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Oxurion is currently recruiting patients for the Phase 2 clinical study of THR-687 in DME.
Oxurion NV has published results1 of its Phase 1 study of THR-687, a novel, highly potent integrin agonist for the treatment of diabetic macular edema (DME, and currently is recruiting patients for Phase 2.
According to the biopharmaceutical company, the multicenter, dose escalation study (NCT03666923) was designed to evaluate the safety and preliminary efficacy of three dose levels of THR-687 (0.4, 1.0 or 2.5mg) in subjects with center-involved DME following a single intravitreal injection.
Patients were eligible for the phase 1 trial if they had center-involved DME with a central subfield thickness (CST) of 320 µm or greater on spectral-domain optical coherence tomography, best corrected visual acuity (BCVA) between 23 and 62 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and a history of and current response to treatment with anti-VEGF or corticosteroid therapy.
As reported from the top line data in 2020, a single injection of THR-687 was safe and well tolerated, showing a very encouraging efficacy signal as measured by a rapid gain in BCVA with 3 months durability and a decrease in CST up to 1 month following the injection.
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.
The company noted that THR-687 will next be investigated in the INTEGRAL Phase 2 study, a randomized, multicenter trial in DME.
This is the first trial in which multiple intravitreal injections of THR-687 will be administered in humans.
The two-part study will assess different dose levels of multiple THR-687 injections (Part A) and then go on to evaluate the efficacy and safety of the selected dose of THR-687 versus aflibercept (the current standard of care) for the treatment of DME (Part B).
The dose selection decision, following Part A, is anticipated in the first half of 2022 and top line data from Part B is expected in the second half of 2023.
According to Tom Graney, CFA, CEO of Oxurion, the promising results from just a single dose of THR-687 have warranted the planning of the Phase 2 study which just opened enrolment of patients.
“There remains a significant unmet medical need in DME and THR-687 has the potential to be a transformative first line therapy for the many patients suffering from this serious condition,” he said. “We would like to thank the patients for their participation in the Phase 1 study as well as the world-class investigators that worked on the trial and the publication.”
Beyond DME, the company noted that THR-687 has the potential to be developed for additional vascular retinal disorders including for wet Age-related Macular Degeneration (wet AMD) and retinal vein occlusion (RVO).
Oxurion focuses on ophthalmic therapies, with a clinical stage portfolio in vascular retinal disorders.
1. Arshad M. Khanani, MD, MA, Sunil S. Patel, MD, et al; Phase 1 Study of THR-687, A Novel, Highly Potent Integrin Antagonist for the Treatment of Diabetic Macular Edema, America Academy of Ophthalmology Journal, August, 17, 2021; doi.org/10.1016/j.xops.2021.100040