OXURION Announces Positive Results from Part A of Phase 2 Study Evaluating THR-149 for Treatment of Diabetic Macular Edema (DME)
Decision taken to move the highest dose of THR-149 (0.13mg) into Part B of the study based on favorable safety profile and positive efficacy data
Oxurion is moving into Part B of study evaluating THR-149 against aflibercept
THR-149 is a potent plasma kallikrein inhibitor for the treatment of the 40-50% of DME patients who respond suboptimally to anti-VEGF therapy
Excerpt from the Press Release:
Leuven, BE, Boston, MA, US – September 30, 2021 – 07.00 AM CET – Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company developing next generation standard of care ophthalmic therapies, today announced positive data from Part A of its Phase 2 study (“KALAHARI”) of THR-149, a plasma kallikrein inhibitor, for the treatment of DME. Based on these data the Company has decided to move the highest dose of THR-149 (0.13mg) into Part B of the study, which is expected to begin shortly.
THR-149, is being developed as a potential new standard of care intravitreal (IVT) therapy for the 40-50% of DME patients showing suboptimal response to anti-VEGF therapy. THR-149 acts through inhibition of the plasma kallikrein-kinin (PKaI-Kinin) system, a validated VEGF-independent target for DME.
Arshad M. Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates, Reno, Nevada, US, comments: “I am excited to see the results from Part A of the KALAHARI study, which was conducted in patients who have shown suboptimal response to anti-VEGF therapy. These patients currently have limited treatment options, and the mean BCVA gains of + 6.1 letters at 3 months with stable CST in patients treated with the highest dose of THR-149 is encouraging. I am looking forward to recruiting patients into Part B of this trial. I am hopeful that the KALAHARI study will demonstrate that THR-149 could benefit the 40-50% of DME patients who respond suboptimally to anti-VEGFs.”
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