Friday May 26th 2023



Oxurion NV (Euronext Brussels: OXUR) a biopharmaceutical company developing next-generation standard of care ophthalmic therapies, with clinical stage assets in vascular retinal disorders, announced today that it has reached its enrollment target of 108 patients randomized in its KALAHARI Phase 2, Part B clinical trial for diabetic macular edema (DME) (KALAHARI trial).

As of today, Oxurion’s investigators have successfully enrolled the 108 patients planned for this trial. Given the high level of interest from both investigators and patients, additional patients are still likely to be included in the trial, which would mean the trial will be over-enrolled.

As it has now reached its enrollment target, Oxurion confirms its previous guidance that it anticipates reporting top-line data from the KALAHARI trial in the fourth quarter of 2023.

“We are thrilled to reach our enrollment target in the KALAHARI trial, and the fact that we are likely to over-enroll is further testament to both the need for this therapy as well as the continued support of our investigators worldwide,” said Andy De Deene, MD, MBA, Chief Development Officer of Oxurion. “The outcome of this trial, which is evaluating THR-149 for the treatment of DME against the current standard of care, aflibercept, could, if positive, provide an important alternative for the up to 50% of patients with DME who respond suboptimally to current anti-VEGF therapies.”

Added Tom Graney, CFA, CEO of Oxurion, said, “Attaining this milestone is an important catalyst for Oxurion as we move towards completion of the KALAHARI trial. With the enrollment target reached, the study is well-positioned to report top-line results by the end of the year. If positive, these results could provide a meaningfully better alternative for the millions of patients worldwide suffering from DME for whom current treatments are not effective. I would like to thank the investigators, their teams, our amazing team, and most of all the patients, for progressing this important trial on behalf of the broader retinal community.”

The KALAHARI trial is evaluating Oxurion’s novel plasma kallikrein (PKal) inhibitor THR-149 as a potential treatment for DME patients who respond suboptimally to anti-VEGF therapy, the current standard of care. This milestone follows the recommendation from an Independent Data Monitoring Committee (IDMC) in December 2022 that the KALAHARI trial should 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 the three-month time point.