Oxurion NV announced top-line results from Part A of its Phase 2 trial (“INTEGRAL”) of THR-687, an integrin antagonist, for the treatment of diabetic macular edema (DME). The Part A data showed THR-687 to be safe and well tolerated with no serious adverse events and none of the patients required rescue medication through Month 3, however, there was insufficient evidence of efficacy on the key endpoints (Best-Corrected Visual Acuity and Central Subfield Thickness). As a result, Oxurion has decided not to advance THR-687 to Part B of the INTEGRAL trial.

The company is therefore fully focused on THR-149 which recently demonstrated a compelling safety and efficacy profile in patients with DME in the first part of the two-part Phase 2 KALAHARI trial. Part B of that trial is currently enrolling patients in the US and Europe. The INTEGRAL trial is a two-part, randomized, prospective, multicenter trial assessing multiple injections of THR-687 in treatment naïve DME patients.

The Part A endpoints were safety (n = 16) and efficacy (n = 14), with two dose levels of THR-687 (1.2mg and 2.0mg) each administered in three monthly IVT injections. Patients are being followed-up until month six of Part A of the trial, and it looks forward to presenting the full data set at an upcoming medical conference.