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06.05.2025 14:00:25

Boehringer Ingelheim starts Phase II study of its potential first-in-class oral compound as a treatment for Geographic Atropy

Ingelheim, Germany, May 6, 2025 – Boehringer Ingelheim today announces the start of the JADE Phase II clinical study (NCT06769048), investigating the efficacy and safety of BI 1584862 as a potential first-in-class treatment for geographic atrophy (GA).[1]  

Geographic atrophy (GA) is an eye disease that can lead to irreversible vision loss.[2] It affects more than five million people worldwide, of which more than 40% are considered blind, ,[3],[4]  severely impacting their independence, mental health and quality of life.[5] GA is an advanced and severe form of age-related macular degeneration (AMD), a chronic and progressive retinal disease.  There is a high unmet need for treatments that stop or slow disease progression and help people maintain their way of life. 

BI 1584862, a phospholipid modulator developed by Boehringer Ingelheim, is an investigational compound with the potential to be a first-in-class oral treatment for GA, being explored to preserve patient vision. [6] It is Boehringer Ingelheim’s second eye health asset in GA moving to Phase II, following the advancement of the investigational compound BI 771716.[7]   

BI 771716 (NCT06722157) is a highly specific antibody fragment designed to optimize penetration through the retinal layers to target the GA pathology. BI 771716 was developed by Boehringer Ingelheim using CDR-Life's proprietary technology. Based on its molecular properties, BI 771716 has the potential to achieve unprecedented efficacy.  

"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. 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,” said Karl Csaky, M.D., Ph.D., Principal Investigator of the Phase II trial and Chief Executive and Medical Officer, Retina Foundation of the Southwest. "An oral treatment could alleviate the burden of existing treatment regimens and offer the opportunity to address both eyes simultaneously in patients with bilaterial disease. 

"At Boehringer Ingelheim, we recognize the need for treatments that address the diverse needs of GA patients and of the medical community. 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,” said Patrick Bussfeld, M.D., Global Head of Medicine, Eye Health at Boehringer Ingelheim. "By exploring multiple avenues, we are seeking to offer more individualized treatment options and, ultimately, improve the quality of life for people living with geographic atrophy."

The announcement of the start of the two Phase II clinical trials in GA 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 that is dedicated to addressing areas of unmet need across retinal conditions.

 

 

About BI 1584862

BI 1584862 is an investigational phospholipid modulator compound intended to limit the further growth of GA by targeting inflammation and preserving vascular function. The compound was discovered and developed by Boehringer Ingelheim and is part of its research and development portfolio in retinal conditions.

About BI 771716

BI 771716, developed by Boehringer Ingelheim using CDR-Life’s proprietary technology, 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. CDR-Life and Boehringer Ingelheim initiated their collaboration and licensing agreement in May 2020. BI 771716 is part of Boehringer Ingelheim’s research and development portfolio in retinal conditions.  

 

About Geographic Atrophy (GA)

Age-related macular degeneration (AMD) is an age-related disease of the central portion of the retina (the macula) which is responsible for high visual acuity that allows for color vision, reading and facial recognition. 5 Geographic atrophy (GA) is an advanced and severe form of AMD that progresses slowly but can lead to permanent vision loss. 5 More than 5 million people worldwide suffer from GA, of which more than 40% are legally blind. 2,3,4 From age 50 years, the prevalence of GA quadruples every 10 years.[8] Consequently, rising incidences are expected in aging populations.  

 

People with GA experience moderate to severe central vision loss, which can impact daily life activities such as driving, shopping alone, reading, finding street signs and a wide range of social and manual activities that require fine motor control.5  These limitations can lead to a loss of independence and social isolation, which in turn can have an impact on mental health, leading to depression, fear and anxiety. 5

 

About Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 54,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at www.boehringer-ingelheim.com

 

Boehringer Ingelheim’s Intended Audiences Notice

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

 

References



[1] ClinicalTrials.Gov. A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy. Available at: https://clinicaltrials.gov/study/NCT06769048?cond=BI%201584862&rank=5. Accessed: May 2025.

[2] Rahimy E, et al. Progression of Geographic Atrophy: Retrospective Analysis of Patients from the IRIS® Registry (Intelligent Research in Sight). Ophthalmol Sci. 2023 Apr 19;3(4):100318. 

[3] Wong WL, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.

[4] Colijn JM et al. Enlargement of Geographic Atrophy From First Diagnosis to End of Life. JAMA Ophthalmol. 2021;139(7):743-750.

[5] Sacconi R, et al. A Review of Current and Future Management of Geographic Atrophy. Ophthalmol Ther 2017;6:69-77.

[7] ClinicalTrials.Gov. A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy (VERDANT). Available at: https://clinicaltrials.gov/study/NCT06722157?cond=BI%20771716&rank=1. Accessed: May 2025.

[8] Rudnicka AR, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta-analysis. Ophthalmology. 2012 Mar;119(3):571-80.


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