A Nonrandomized Phase 2 Trial of EG-Mirotin, a Novel, First-in-class, Subcutaneously Delivered Peptide Drug for Non-Proliferative Diabetic Retinopathy

AimEG-Mirotin (active ingredient EGT022) targets non-proliferative diabetic retinopathy (NPDR), the early stage of retinopathy. EG-Mirotin reverses capillary damage before NPDR progresses to an irreversible stage. EG-Mirotin safety and efficacy were investigated in patients with type 1 or type 2 diabetes mellitus and moderate-to-severe NPDR. MethodsIn this open-label, single-arm, single-center, exploratory phase II study, 10 patients (20 eyes) received EG-Mirotin once a day (3 mg/1.5 ml sterile saline) for 5 days and were evaluated for ischemic index changes and safety. End-of-study was approximately 8{+/-}1 weeks (57{+/-}7 days) after the first drug administration. ResultsEG-Mirotin injections were well tolerated with no dose-limiting adverse events, serious adverse events, or deaths. Four treatment-emergent adverse events (TEAEs) unrelated to the investigational drug were observed in 2 out of 10 participants (20.00%) who had received the investigational drug. The overall average percent change in ischemic index at each evaluation point compared to baseline was statistically significant (Greenhouse-Geisser F=9.456, p=0.004 for the main effect of time), and a larger change was observed when the baseline ischemic index value was high (Greenhouse-Geisser F=10.946, p=0.002 for time x group interaction). ConclusionsEG-Mirotin was well tolerated and reversed diabetes-induced ischemia and leakage of capillaries in the retina.