Boehringer Announces Start of Phase II Geographic Atrophy Trial of Potential First-in-Class Therapy
The JADE study will be evaluating BI 1584862, an investigational oral compound that targets inflammation and preserves vascular function.
Boehringer Ingelheim has announced the start of the JADE Phase II clinical trial (NCT06769048), evaluating the efficacy and safety of BI 1584862 as a potential first-in-class treatment for geographic atrophy (GA). BI 1584862, a phospholipid modulator, was discovered and developed in-house by Boehringer. It intends to limit the growth of GA by targeting inflammation and preserving vascular function.1
In a press release, Karl Csaky, MD, PhD, principal investigator of the Phase II trial and chief executive and medical officer, Retina Foundation of the Southwest, said: “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. 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.”
The JADE study is open to adults aged 55 years and older with GA that was diagnosed by imaging of the retina. It has four treatment groups comprised of multiple BI 1584862 doses and a placebo arm. The primary endpoint of the study is slope of change from baseline in square root transformed GA area as measured by fundus autofluorescence over a treatment period of up to 50 weeks. Participants will be in the study for one year.2
In the press release, Patrick Bussfeld, MD, PhD, global head of medicine, eye health at Boehringer Ingelheim, added: “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. 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."
As Bussfeld mentioned, Boehringer is evaluating another potential GA treatment in BI 771716. The investigational antibody fragment was developed by Boehringer along with technology licensed from CDR-Life. In September 2024, Boehringer announced plans to further advance the potential therapy following positive Phase I results. In the study (NCT06006585), BI 771716 achieved its primary safety endpoint following intravitreal administration of single and multiple doses.3
In a press release from the time, Heiko Niessen, PhD, global therapeutic area head translational medicine & clinical pharmacology retinal health at Boehringer Ingelheim, 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.”
Charles C. Wykoff, MD, PhD, principal investigator of the Phase I trial, director of research at Retina Consultants of Texas; chair of research, Retina Consultants of America; and deputy chair of ophthalmology for the Blanton Eye Institute, Houston Methodist Hospital, added: “The development of new therapies for geographic atrophy remains one of the most important needs in the age related macular degeneration space. Achieving the Phase I safety endpoint is a meaningful step forward for this potential new treatment for people with this sight-threatening and life-affecting condition.”
References
1. Boehringer Ingelheim starts Phase II study of its potential first-in-class oral compound as a treatment for Geographic Atrophy. News release. Boehringer Ingelheim. May 6, 2025. Accessed May 8, 2025. https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-ii-start-oral-treatment-geographic-atrophy
2. A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy. ClinicalTrials.gov. Accessed May 8, 2025. https://clinicaltrials.gov/study/NCT06769048?cond=BI%201584862&rank=5
3. Boehringer Ingelheim announces plans to advance potential new treatment for Geographic Atrophy, following positive Phase I results. News release. Boehringer Ingelheim. September 5, 2024. Accessed May 8, 2025. https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/geographic-atrophy-treatment-move-phase-ii
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