Oxurion NV announced that topline data in its KALAHARI Phase 2, Part B clinical trial for Diabetic macular edema (DME) (KALAHARI trial) did not demonstrate that its novel PKal Inhibitor, THR-149, improved vision as much as the comparator, the anti-VEGF therapy aflibercept, at Month 3 (the primary endpoint). The mean change in best corrected visual acuity (BCVA) from baseline at Month 3 was -0.2 letters for theTHR-149 arm and +3.5 letters for the aflibercept arm. The results confirmed that THR-149 was safe and well tolerated.

The KALAHARI trial is the only ongoing trial sponsored by Oxurion. In light of these results and the Company's low cash position, the Company has therefore decided to take the necessary steps to file for bankruptcy. Oxurion's investigators over-enrolled the trial with a total of 112 patients, for whom the current standard of care is suboptimal in treating their DME, reflecting the strong interest of both investigators and patients.

The KALAHari trial evaluated Oxurion's novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for DME patients who respond suboptimally to anti-VEGF therapy. The continuation of the trial followed the recommendation from an Independent Data Monitoring Committee (IDMC) in December 2022 that it would not be futile for the KALAHARI trial to continue based on the outcome of a pre-specified futility analysis that included an evaluation of interim efficacy and safety data from 31 patients at Month 3 and followed encouraging data from the Part A dose- selection part of the KALAHARI trial.