Boehringer Starts Phase II Trial for Oral Drug in Geographic Atrophy

Boehringer Ingelheim 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).

Geographic atrophy (GA) is an eye disease that can lead to irreversible vision loss. It affects more than five million people worldwide, of which more than 40% are considered blind, severely impacting their independence, mental health and quality of life. 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. ?It is Boehringer Ingelheim’s second eye health asset in GA moving to phase II, following the advancement of the investigational compound BI 771716.  

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., Ph.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.  

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.

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.??

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. Geographic atrophy (GA) is an advanced and severe form of AMD that progresses slowly but can lead to permanent vision loss. More than 5 million people worldwide suffer from GA, of which more than 40% are legally blind. From age 50 years, the prevalence of GA quadruples every 10 years. 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. 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.

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!