Oxurion initiated the bankruptcy filing process following the unsuccessful Phase IIb trial of its diabetic macular edema (DME) drug, THR-149, which did not achieve its primary endpoint.
The company, headquartered in Belgium, attributed its decision to file for bankruptcy to insufficient cash reserves.
According to a news release from Oxurion, the topline data from its KALAHARI Phase 2, Part B clinical trial for diabetic macular edema (DME) (KALAHARI trial) did not show significant improvement in vision with its novel PKal Inhibitor, THR-149, compared to the anti-VEGF therapy aflibercept, at Month 3 (the primary endpoint). At Month 3, the mean change in best-corrected visual acuity (BCVA) from baseline was -0.2 letters for the THR-149 arm and +3.5 letters for the aflibercept arm.
The trial conducted by Oxurion enrolled a total of 112 patients, surpassing the intended enrollment, all of whom experience suboptimal treatment outcomes with the current standard of care for their diabetic macular edema (DME). This higher enrollment reflects the keen interest from both investigators and patients.
In the KALAHARI trial, Oxurion assessed the potential of its novel plasma kallikrein (PKal) inhibitor, THR-149, as a treatment for DME patients who do not respond optimally to anti-VEGF therapy. The decision to continue the trial was made based on the recommendation of an Independent Data Monitoring Committee (IDMC) in December 2022. The IDMC determined that it was not futile for the KALAHARI trial to proceed, taking into account the results of a pre-specified futility analysis that included an assessment of interim efficacy and safety data from 31 patients at Month 3. This decision was supported by positive data from the Part A dose-selection phase 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. The Board of Directors has made the difficult decision to take the necessary steps to file for bankruptcy,” said Tom Graney, CEO.