Boehringer Ingelheim and CDR-Life have announced positive results from the Phase I evaluation of BI 771716, an investigational antibody fragment designed to preserve vision in individuals with geographic atrophy (GA). The successful completion of the Phase I trial, which met its primary safety endpoint, paves the way for a Phase II study slated to begin in early 2025.
Phase I Trial Highlights Safety and Tolerability
The Phase I trial (NCT06006585) assessed the safety, tolerability, and pharmacokinetics of BI 771716 following intravitreal administration of single and multiple doses in patients aged 50 and older with geographic atrophy. The study comprised two parts: a single rising dose (SDR) arm and a multiple-dose (MD) arm. In the SDR arm, participants received a single injection of BI 771716 directly into one eye affected by GA. The primary endpoint was the number of patients with ocular dose-limiting events until Day 8. Secondary endpoints included the occurrence of any ocular adverse events (AEs) and maximum serum concentration (Cmax) of BI 771716 after a single intravitreal dose.
In the multiple-dose arm, participants received two injections of BI 771716, administered four weeks apart. The trial's success in meeting its primary safety endpoint marks a significant milestone in the drug's development.
Addressing Unmet Needs in Geographic Atrophy
Geographic atrophy, an advanced form of late-stage dry age-related macular degeneration (AMD), is a chronic and progressive retinal disease leading to irreversible vision loss. Affecting over 5 million people worldwide, with more than 40% considered blind, GA represents a significant unmet medical need. Current treatment options are limited, highlighting the importance of developing new therapies like BI 771716.
Mechanism of Action and Future Development
BI 771716, developed using technology licensed from CDR-Life, is a highly specific antibody fragment designed for optimized penetration through retinal layers to reach critical target sites driving GA pathology. Its molecular properties are intended to enhance efficacy. Boehringer Ingelheim is now preparing for a Phase II clinical study to investigate the efficacy and dosing of BI 771716.
According to Charles C. Wykoff, MD, PhD, a principal investigator in the Phase I trial, the development of new therapies for geographic atrophy remains one of the most important needs in the age-related macular degeneration space. He emphasized that achieving the Phase I safety endpoint is a meaningful step forward for this potential new treatment.
