Boehringer Ingelheim to advance new Geographic Atrophy treatment after positive Phase I results

INGELHEIM, Germany and BASEL, Switzerland I September 5, 2024 I Boehringer Ingelheim and CDR-Life have announced successful results from Phase I testing of BI 771716, an investigational antibody fragment aimed at preserving vision in individuals with geographic atrophy (GA). This milestone follows the intravitreal administration of both single and multiple doses, with the primary safety endpoint being met. The companies are now preparing for the Phase II trial, which is scheduled to commence in early 2025.

GA represents an advanced form of late-stage dry age-related macular degeneration (AMD), a progressive retinal disease that can cause permanent vision loss. Affecting over five million people globally, GA is a leading cause of blindness, with more than 40% of those affected classified as blind. The condition not only impairs vision but also significantly affects the independence and quality of life of those living with it. Current treatment options offer limited efficacy and availability.

BI 771716, developed by Boehringer Ingelheim using technology licensed from CDR-Life, is a highly specific antibody fragment designed to penetrate all retinal layers effectively, targeting the areas most critical to GA pathology. The molecular properties of BI 771716 suggest it holds the potential for unprecedented efficacy in treating GA.

"We are delighted to have reached a critical milestone in the development of BI 771716 and are now preparing to investigate its efficacy and dosing in a Phase II clinical study," said Heiko Niessen, Ph.D., Global Therapeutic Area Head, Translational Medicine & Clinical Pharmacology, Retinal Health at Boehringer Ingelheim. "BI 771716 is part of our extensive retinal portfolio, underlining our commitment to preserving eyesight and quality of life in individuals with retinal diseases."

Christian Leisner, Ph.D., CEO of CDR-Life, expressed optimism about the continued development of BI 771716. "Reaching this safety milestone underscores the strength of our partnership with Boehringer Ingelheim. Having successfully met all four planned milestones, we are hopeful that this innovative therapy will provide significant clinical benefits for those with geographic atrophy."

Charles C. Wykoff, MD, Ph.D., Principal Investigator of the Phase I trial, emphasized the importance of developing new therapies for GA. "Achieving the Phase I safety endpoint marks a meaningful step forward in developing this potential new treatment for those with this debilitating condition," he said.

The collaboration between Boehringer Ingelheim and CDR-Life began in May 2020, with the selection of an antibody fragment-based therapeutic candidate in September 2021. Since then, the companies have successfully met all set milestones.

The Phase I trial assessed the safety, tolerability, and pharmacokinetics of intravitreal single rising doses and multiple doses of BI 771716 in patients over 50 years old suffering from geographic atrophy. The study consisted of two parts: a single rising dose phase, where participants received one injection of BI 771716, and a multiple dose phase, where participants received two injections spaced four weeks apart. The primary goal was to determine the number of patients experiencing ocular dose-limiting events, while secondary goals included recording any ocular adverse events and measuring the maximum serum concentration of BI 771716 after a single intravitreal dose.

Geographic atrophy is a severe form of AMD that affects a significant portion of the central retina, leading to permanent vision loss in many cases. The prevalence of GA increases significantly with age, particularly in populations over 50 years old. Those affected by GA experience central vision loss, impacting daily activities and potentially leading to social isolation and mental health issues.

Boehringer Ingelheim is committed to developing innovative therapies that transform lives. Founded in 1885, the research-driven biopharmaceutical company employs over 53,000 people and serves more than 130 markets globally. CDR-Life, focused on developing potent T-cell engagers to combat hard-to-treat cancers, leverages a robust antibody-based platform to target a broad range of cancer antigens. The partnership with Boehringer Ingelheim highlights a shared commitment to innovation in addressing unmet medical needs.

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