Oxurion NV announced it is planning an interim analysis of at least 25% of the patients for the KALAHARI Phase 2, Part B clinical trial. Results of the interim analysis are expected by year-end 2022 and full top-line data from the trial is now expected in the second half of 2023. The KALAHARI trial is evaluating Oxurion's novel plasma kallikrein (PKal) candidate, THR-149, as a potential treatment for patients who respond suboptimally to anti-VEGF standard of care for treatment of diabetic macular edema (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. Part B follows Part A of the study, in which three dose levels of THR-149 (0.005mg, 0.022mg and 0.13mg), were each administered in three monthly IVT injections, were evaluated in order to select the best dose for Part B of the study. High-level Month 3 data from Part A of the KALAHARI trial was first presented in October 2021 and demonstrated that in the eight patients who received the high dose of THR-149, a mean BCVA gain of 6.1 letters at Month 3, the primary endpoint, was observed.

A post-hoc analysis of an OCT (Optical Coherence Tomography) biomarker assessment, was performed by the masked central reading center in February 2022. The masked reading center identified two subjects with abnormalities at baseline, which could impact responsiveness to any medical treatment. Excluding these two subjects resulted in an improvement in mean BCVA of 9.3 letters at Month 3 that was sustained until Month 6, the end of the trial.

The six-month data also demonstrated THR-149's attractive safety profile and its ability to stabilize the Central Subfield Thickness (CST). The learnings from the Part A data were incorporated into Part B through an amended study design.