Oxurion NV 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 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. The Phase 2 KALAHARI study is a two-part, randomized, prospective, multi-center study assessing multiple injections of THR-149 in DME patients who have previously shown a suboptimal response to anti-VEGF therapy. The endpoints of Part A of the study were safety (n= 23) and efficacy (n = 20). In Part A of the study, three dose levels of THR-149 (0.005mg, 0.022mg and 0.13mg), each administered in three monthly IVT injections, were evaluated in order to select the best dose for Part B of the study. Results from Part A showed that all dose levels of THR-149 had a favorable safety profile, with no serious adverse events being observed. All adverse events in the study eye were mild to moderate in intensity and no severe ocular adverse events were reported. Finally, no inflammation was seen in the study eye of any patient at any dose evaluated in Part A of the study. When assessing efficacy, three IVT injections of THR-149 (0.13mg) delivered the most promising results in terms of Best Corrected Visual Accuity (BCVA), the primary endpoint for registration in DME, and also delivered a stable Central Subfield Thickness (CST), a promising result in a population were if left untreated CST would be expected to deteriorate. No patients in the high dose group (n = 8) required rescue medication. In terms of BCVA, the dose delivered a mean 6.1 letter improvement at Month 3. The range of BCVA changes with the dose was -0.4 to 12.6 letters at Month 3. In terms of CST, the dose showed a stable CST (mean change of 13 µm) at Month 3. The range of CST changes with the dose was -37.1 to 63.6 µm at Month 3.