Oxurion finalizes enrollment in KALAHARI Phase 2, Part B trial of novel PKal inhibitor THR-149 in diabetic macular edema

Oxurion’s investigators have successfully over-enrolled the trial with a total of 112 patients, compared to the original 108 patients planned, reflecting the strong interest of both investigators and patients. With the completion of enrollment, Oxurion confirms its previous guidance that it expects to report top-line data from the KALAHARI trial in the fourth quarter of 2023.

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. The completion of enrollment 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.

Diabetic Macular Edema (DME)

Approximately 22 million people worldwide have DME currently, with prevalence increasing due to the growing global diabetic epidemic. DME is the leading cause of vision loss in working-age people, and the market for treatments is currently estimated at +$5 billion.

People who suffer from DME have leaking vessels in the back of the eye, leading to a thickening of the retina that causes vision problems such as blurriness in the center of vision, the appearance of dark spots or patches in the field of vision, and colors to look dull. These symptoms may affect the ability to read, write, drive, and recognize faces – presenting a significant patient and caregiver burden.