Oxurion doses first patient in phase 2 DME study
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Oxurion NV has dosed the first patient in a phase 2 study examining THR-149 in the treatment of diabetic macular edema, according to a press release.
The study, Kalahari, is a randomized, prospective, multicenter investigation looking at the impact of multiple injections of THR-149, a plasma kallikrein inhibitor, in patients whose response to anti-VEGF treatment is suboptimal.
Eighteen patients will be enrolled in the dose-finding part of the study, with results expected in 2021. Approximately 104 patients will then be recruited into the double-masked, active-controlled evaluation of the selected dose compared with aflibercept. Top line results are expected in 2023.
In the phase 1 study reported previously, visual acuity gains were maintained at day 90 after a single injection of THR-149.
“Starting this clinical trial is an important step towards potentially bringing THR-149, a novel and promising plasma kallikrein inhibitor, to patients with DME,” Charles C. Wykoff, MD, PhD, director of research at Retina Consultants of Houston, said in the release.
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