Oxurion to File for Bankruptcy After Failed DME Trial

Oxurion said it has decided to file for bankruptcy after announcing topline data from its KALAHARI phase 2, Part B trial for diabetic macular edema (DME). The trial did not demonstrate that its novel PKal inhibitor, THR-149, improved vision as much as the comparator, 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 the THR-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.

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.

“We are deeply disappointed that the topline data from the KALAHARI trial did not show improvement in vision from THR-149. While we had hoped for a different result for patients, we greatly appreciate the engagement of both the patients and the clinical investigators for their participation in phase 2 KALAHARI trial," Tom Graney, CEO of Oxurion, said in a company news release. "The Board of Directors has made the difficult decision to take the necessary steps to file for bankruptcy. I would personally like to thank the incredible team at Oxurion for designing and executing a trial that yielded clearly interpretable results. So, while the outcome is not what we had hoped for patients and the company, the trial provides important learnings for the field. I want to encourage the community to continue to invest in finding better treatments options for this large, underserved patient population.”