The trial met the pre-specified criterion for early efficacy of foveal avascular zone area stabilisation compared to sham at week 16. Credit: PeopleImages.com – Yuri A / Shutterstock.com.

Boehringer Ingelheim has reported positive data from the HORNBILL Phase I/IIa clinical trial of the humanised monoclonal anti-Sema3A antibody, BI 764524, as a potential treatment for diabetic macular ischemia (DMI).

The HORNBILL study was divided into two parts: a single rising dose (SRD) and multiple dose (MD) segments.

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In the open-label, non-randomised SRD part, 12 patients were administered 0.5mg, 1mg, or 2.5mg intravitreal doses of BI 764524.

The number of subjects experiencing dose-limiting events (DLEs) was the primary endpoint while secondary endpoints comprised drug-related adverse events (AEs) and ocular AEs.

In the masked, randomised, sham-controlled MD segment of the trial, 31 patients received three intravitreal 2.5mg BI 764524 doses or a sham injection at four-week intervals.

The primary endpoint was the number of subjects with drug-related AEs, while secondary endpoints included ocular AEs, changes from baseline in foveal avascular zone (FAZ) area, best corrected visual acuity (BCVA), and central retinal thickness (CRT).

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In the trial, BI 764524 demonstrated to be well tolerated following intravitreal administration of single and multiple doses, thereby meeting its primary safety endpoints and showed initial efficacy signs.

Furthermore, the trial met the pre-specified criterion for early efficacy of foveal avascular zone area stabilisation compared to sham at week 16.

This data indicates that BI 764524 could positively impact retinal non-perfusion to hinder the capillary loss progression.

The upcoming Phase IIb CRIMSON study will further assess the safety and efficacy of BI 764524 in patients with diabetic retinopathy (DR) and is expected to begin recruitment later in the year.

Boehringer Ingelheim Retinal Health head Ulrike Graefe-Mody said: “Vision loss associated with retinal conditions such as diabetic retinopathy and DMI has a devastating impact on quality of life. The results are an important step towards achieving our aspiration of developing precision therapies delivering the right treatment for the right patient at the right time to prevent vision loss before irreversible damage occurs.

“We’re looking forward to start a Phase IIb study to further explore the safety and efficacy of BI 764524.”

Last week, Boehringer and US-based pharmacy store chain Walgreens have entered into a strategic partnership to optimise clinical trial recruitment and improve accessibility, inclusivity and equity.