Oxurion NV announced the completion of patient enrollment into Part A of its two part phase 2 study (KALAHARI) evaluating multiple injections of THR-149 for the treatment of DME. Dose selection data from Part A of the study is expected in the second half of 2021.
THR-149, Oxurion’s most advanced drug candidate, is being developed to potentially become the treatment of choice for the up to 40% of DME patients, who respond suboptimally to anti-VEGF therapy. THR-149 acts through inhibition of the plasma kallikrein-kinin (PKaI-Kinin) system, a validated VEGF-independent target for DME.
A single dose phase 1 study showed that THR-149 was well-tolerated, safe and delivered promising efficacy results, particularly improvements in patients’ Best Corrected Visual Acuity (BCVA), the primary endpoint for registration in DME. A rapid onset of action was observed from Day 1, across all doses, with an increasing average improvement in BCVA of up to 7.5 letters at Day 14. Importantly, this visual gain was maintained with an average improvement in BCVA of 6.4 letters at Day 90.
The phase 2 KALAHARI study is a two part, randomized, prospective, multicenter study assessing multiple (3) injections of THR-149 in DME patients who suboptimally respond to anti-VEGF therapy. In Part A of the study, three dose levels of THR-149, each administered in 3 monthly intravitreal injections, are being tested in at least 18 patients to select the optimal dose for Part B.
Tom Graney, CFA, Chief Executive Officer of Oxurion, comments, “We are very pleased to announce the completion of patient enrollment into Part A of our phase 2 study evaluating THR-149 for the treatment of DME, particularly given the challenges posed by the continuing Covid-19 situation. This milestone positions us to report the important initial Part A data in the second half of the year. These data, if positive, will provide proof of concept and be a significant derisking event for the company. This patient population currently does not have adequate treatment options and represents a critical area of unmet medical need in the treatment of diabetic macular edema.”
Part B (n≈104) is the double-masked, active-controlled part of the study with the dose selected from Part A studied against aflibercept as the active comparator. Final topline results from Part B of the study are expected in the first half of 2023.