Investigational compound shows promise in treatment of diabetic macular ischemia
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PARK CITY, Utah — Outcomes from the phase 1/2a HORNBILL study indicate a potential disease-modifying effect of BI 764524 in eyes with diabetic macular ischemia.
Regarding safety, single and multiple intravitreal injection doses were well tolerated, Quan Dong Nguyen, MD, MSc, said at Clinical Trials at the Summit.
Currently, no approved treatment is available for diabetic macular ischemia (DMI). BI 764524 (Boehringer Ingelheim) is an investigational drug targeting semaphorin 3A (Sema3A), a complex molecule involved in the processes of dysregulation of angiogenesis and increased retinal permeability, leading to the development of DMI in patients with diabetic retinopathy. By binding and neutralizing Sema3A, this novel compound may affect retinal nonperfusion and promote revascularization of ischemic areas.
In part A of the HORNBILL study, three doses of the compound — 0.5 mg, 1 mg and 2.5 mg — were tested in 12 subjects. The 2.5 mg dose was selected as the most appropriate dose for part B of the study, in which 20 subjects were treated with three injections of BI 764524 at day 1, week 4 and week 8, with follow-up to week 22, while 10 subjects received sham injection.
The study met its prespecified criterion for early efficacy of foveal avascular zone (FAZ) area stabilization vs. sham.
“The FAZ for the sham group seemed to be increased overall in the area of the nonperfusion, while in the treatment group there was evidence of decrease in the size of the FAZ,” Nguyen said.
OCT angiography of one patient showed evidence of formation of new blood vessels in the treated eyes at 4 months as compared with baseline.
No dose-limiting or drug-related adverse events or signs of inflammation were reported with the single standard dose or multiple doses.
Based on these findings, BI 764524 is moving forward in the phase 2b CRIMSON study, an international study looking at the effects of BI 764524 in patients with moderately severe to severe nonproliferative diabetic retinopathy, Nguyen said.
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Nguyen QD, et al. Outcomes of the HORNBILL study: A phase I/IIa trial investigating BI 764524 in patients with diabetic macular ischemia. Presented at: Clinical Trials at the Summit; June 8, 2024; Park City, Utah.
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