Boehringer declares positive findings from diabetic macular ischemia trial

Boehringer Ingelheim released positive findings from the HORNBILL Phase I/IIa trial assessing BI 764524, a humanized monoclonal anti-Sema3A antibody, for diabetic macular ischemia (DMI).

The study had two parts: a single rising dose (SRD) and multiple dose (MD) segments.

In the SRD part, 12 patients received 0.5mg, 1mg, or 2.5mg intravitreal doses. Primary endpoint: dose-limiting events (DLEs); secondary: drug-related adverse events (AEs) and ocular AEs.

The MD segment was masked and sham-controlled, with 31 patients receiving three 2.5mg doses or a sham injection. Primary endpoint: drug-related AEs; secondary: ocular AEs, changes in foveal avascular zone (FAZ) area, best-corrected visual acuity (BCVA), and central retinal thickness (CRT).

BI 764524 was well tolerated, meeting primary safety endpoints and showing initial efficacy. It stabilized the FAZ area compared to sham at week 16, suggesting a positive impact on retinal non-perfusion and potential inhibition of capillary loss.