Oxurion NV announced updates on its two clinical programs, THR-687, initially being developed for first line treatment of DME, and THR-149 being developed for second line treatment of DME.THR-687 is a potential best-in-class small molecule pan-RGD integrin antagonist being developed for the treatment of DME and holding promise for the treatment of wet Age-related Macular Degeneration (wAMD) and macular edema following Retinal Vein Occlusion (RVO). The INTEGRAL trial is a two-part Phase 2, randomized, multi-center clinical trial and is the first trial in which multiple intravitreal injections of THR-687 will be administered in humans. Part A of the trial will assess two dose levels of multiple THR-687 injections and, if successful, the trial's results will be used to select the appropriate dose for Part B of the INTEGRAL trial that will evaluate the efficacy and safety of THR-687 versus aflibercept (the current standard of care) for the treatment of DME.

Part B of the trial will include both treatment experienced and treatment naïve subjects. The dose selection decision, following Part A, is anticipated in the first half of 2022 with top line data from Part B expected in the second half of 2023. The post-hoc analysis of the Part A results identified opportunities to optimize the inclusion and exclusion criteria for Part B for both probability of success and speed.

Part B of the KALAHARI trial is ongoing, assessing three monthly injections of THR-149, compared to three monthly injections of aflibercept, up to Month 3. As from Month 3, the safety and efficacy of a switched fourth injection (THR-149 to aflibercept or aflibercept to THR-149) will be evaluated in about half of the subjects whereas in the other half of the subjects the durability of three monthly injections (THR-149 or aflibercept) will be evaluated through a single sham injection. The trial is planned to randomize approximately 108 subjects in Part B and the primary endpoint remains the mean change in BCVA letter score from baseline, at Month 3.