Boehringer Ingelheim announced today the commencement of the JADE Phase II clinical study (NCT06769048) to investigate the efficacy and safety of BI 1584862 as a potential first-in-class oral treatment for geographic atrophy (GA). This development marks a significant step forward in addressing a condition that currently has limited treatment options.
Geographic atrophy, an advanced and severe form of age-related macular degeneration (AMD), affects more than five million people worldwide. The progressive eye disease leads to irreversible vision loss, with over 40% of patients considered legally blind. This condition severely impacts patients' independence, mental health, and overall quality of life.
BI 1584862, a phospholipid modulator developed by Boehringer Ingelheim, represents a novel approach to treating GA. The compound is designed to limit the further growth of GA by targeting inflammation and preserving vascular function. If successful, it would be the first oral treatment for this condition, potentially transforming the treatment landscape.
Dual-Pathway Approach to Geographic Atrophy
The JADE study is part of Boehringer Ingelheim's broader strategy in eye health. The company is simultaneously advancing another investigational compound, BI 771716, which has also progressed to Phase II clinical trials. Unlike BI 1584862, BI 771716 is a highly specific antibody fragment designed to optimize penetration through the retinal layers to target GA pathology directly.
"At Boehringer Ingelheim, we recognize the need for treatments that address the diverse needs of GA patients and of the medical community," said Patrick Bussfeld, M.D., Global Head of Medicine, Eye Health at Boehringer Ingelheim. "Our commitment is reflected in our Phase II clinical trials investigating two distinct compounds, BI 1584862 and BI 771716, each targeting different pathways. This approach highlights our dedication to providing tailored solutions that support the individual needs of people living with the condition."
BI 771716 was developed using proprietary technology from CDR-Life, following a collaboration and licensing agreement initiated in May 2020. Based on its molecular properties, the company believes this compound has the potential to achieve unprecedented efficacy in treating GA.
Addressing Patient Burden
The impact of geographic atrophy extends far beyond vision loss. Patients often struggle with daily activities such as driving, shopping, reading, and recognizing faces. These limitations frequently lead to loss of independence and social isolation, which can trigger depression, fear, and anxiety.
Karl Csaky, M.D., Ph.D., Principal Investigator of the Phase II trial and Chief Executive and Medical Officer at the Retina Foundation of the Southwest, emphasized the significance of developing an oral treatment option: "Vision loss associated with geographic atrophy profoundly affects the lives of those impacted, particularly older adults, making daily activities more difficult. The loss of independence has a significant burden for patients, caregivers and society overall."
Dr. Csaky added, "I'm excited to see that Boehringer Ingelheim is exploring treatment options aimed at reducing the treatment and visit burden for patients and their caregivers. An oral treatment could alleviate the burden of existing treatment regimens and offer the opportunity to address both eyes simultaneously in patients with bilateral disease."
Growing Public Health Concern
The prevalence of geographic atrophy increases dramatically with age, quadrupling every 10 years after age 50. With aging populations worldwide, the incidence of GA is expected to rise significantly in coming decades, making the development of effective treatments increasingly urgent.
Current management options for GA are limited, with a high unmet need for treatments that can stop or slow disease progression and help patients maintain their quality of life. The disease typically progresses slowly but inexorably, leading to permanent vision loss in the central field of vision.
The announcement of these Phase II clinical trials coincides with the Association for Research in Vision and Ophthalmology (ARVO) Annual meeting, where Boehringer Ingelheim is presenting 19 abstracts spanning its diverse Eye Health portfolio. This research focus demonstrates the company's commitment to addressing areas of unmet need across various retinal conditions.
As the JADE study progresses, it will provide valuable insights into the potential of oral therapy for geographic atrophy, potentially offering a more convenient and comprehensive approach to treatment that could significantly improve outcomes for millions of affected patients worldwide.
