Boehringer Ingelheim and CDR-Life on Monday announced positive results from the phase I trial of an investigational antibody fragment developed to preserve vision in people living with geographic atrophy (GA).
According to the company’s statement, BI 771716 met its primary safety endpoint following intravitreal administration of single and multiple doses. Preparation for the phase II trial is now underway, with an expected start date in early 2025.
GA is an advanced and severe form of late-stage, dry age-related macular degeneration (AMD), a chronic and progressive retinal disease, that can lead to irreversible and permanent vision loss. It is a leading cause of blindness, affecting more than five million people worldwide, of which more than 40% are considered blind. Vision loss associated with GA severely impacts the independence, mental health and quality of life of those living with the condition. Current treatments have limited efficacy and availability.
BI 771716, developed by Boehringer Ingelheim with technology licensed from CDR-Life, is a highly specific antibody fragment, possibly enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology, it stated. Based on its molecular properties, BI 771716 has the potential to achieve unprecedented efficacy, the company claims.
“We are delighted to have achieved a critical milestone in our development of BI 771716, and are now preparing a phase II clinical study to investigate efficacy and dosing,” said Heiko Niessen, Ph.D., global therapeutic area head translational medicine & clinical pharmacology retinal health at Boehringer Ingelheim. “BI 771716 is part of our comprehensive retinal portfolio demonstrating our long-term commitment to preserving both eyesight and quality of life in people with retinal diseases.”
CDR-Life and Boehringer Ingelheim announced their collaboration and licensing agreement in May 2020, followed by the selection of an antibody fragment-based therapeutic candidate in September 2021. The companies have executed on all milestones to date, it added.
