Boehringer Ingelheim and CDR-Life have reported positive outcomes from the Phase I clinical trial of BI 771716, a new treatment for geographic atrophy (GA).
BI 771716 is an investigational antibody fragment created to preserve vision in individuals with GA, a severe form of late-stage dry age-related macular degeneration (AMD).
The trial assessed the tolerability, safety, and pharmacokinetics of varying doses of BI 771716 administered intravitreally to patients aged 50 years and above.
It aimed to evaluate the tolerance levels of various BI 771716 doses.
The trial was conducted in two parts: the single rising dose (SRD) and the multiple dose (MD) phases.
In the SRD phase, subjects received a single injection of BI 771716 into one eye affected by GA.
The primary endpoint was the incidence of ocular dose-limiting events (DLEs) from treatment until day eight.
Secondary endpoints included the occurrence of any ocular adverse events (AEs) and the maximum serum concentration (Cmax) of BI 771716 following a single intravitreal dose.
In the MD phase, participants received two injections of BI 771716 into the eye, spaced four weeks apart.
The trial demonstrated that BI 771716 met its primary safety endpoint for both single and multiple doses administered intravitreally.
Preparation for the Phase II trial is now underway, with a planned start date earlier next year, the company noted.
Boehringer Ingelheim translational medicine and clinical pharmacology retinal health global therapeutic area head Heiko Niessen said: “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.
“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.”
Developed by Boehringer in collaboration with CDR-Life, BI 771716 features advanced technology that may allow optimised penetration through retinal layers to target the underlying pathology of GA.
In June, Boehringer Ingelheim and Gubra initiated a Phase I trial of BI 3034701, a long-acting triple agonist peptide designed to treat obesity.
