Highest dose of THR-149 advances in phase 2 DME study
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Oxurion will move the testing of THR-149 0.13 mg into part B of its phase 2 KALAHARI study, which will evaluate the drug compared with aflibercept in patients with diabetic macular edema, according to a company press release.
THR-149, a plasma kallikrein inhibitor delivered intravitreally, has shown positive results at all three dose levels administered in part A of the study to evaluate its safety and efficacy in the treatment of DME. Results demonstrated a favorable safety profile for 0.005 mg, 0.022 mg and 0.13 mg doses of THR-149 with no serious adverse events observed in any group. A mean 6.1-letter improvement in best corrected visual acuity, as well as a stable central subfield thickness, was observed in the highest-dose group at 3 months. None of the eight participants in the highest-dose group required rescue medication.
Part B of the study is designed to enroll more than 100 patients whose previous response to anti-VEGF therapy was suboptimal. The final topline results are expected by mid-2023.
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