Advancements in Vision Preservation: Boehringer Ingelheim’s Breakthrough in Geographic Atrophy Treatment

(IN BRIEF) Boehringer Ingelheim and CDR-Life have reported positive results from the Phase I trial of BI 771716, an investigational treatment for geographic atrophy (GA), a severe form of age-related macular degeneration. The antibody fragment met its primary safety endpoints, leading to plans for a Phase II trial starting in early 2025. GA, which affects over five million people worldwide, currently has limited treatment options. BI 771716 shows potential for better retinal penetration and efficacy. The collaboration between Boehringer Ingelheim and CDR-Life, initiated in 2020, has reached significant milestones, with further development expected to address this critical medical need.

(PRESS RELEASE) INGELHEIM, 6-Sep-2024 — /EuropaWire/ — Boehringer Ingelheim, in partnership with CDR-Life, has announced promising progress in the development of BI 771716, a novel treatment for geographic atrophy (GA). The Phase I trial results reveal that BI 771716, an investigational antibody fragment, successfully met its primary safety endpoints, paving the way for the next phase of development. With Phase II trials scheduled to begin in early 2025, this advancement offers new hope for those affected by GA, a severe form of age-related macular degeneration (AMD) leading to significant vision loss.

Geographic atrophy is a leading cause of blindness affecting over five million people globally, with current treatments offering limited effectiveness. BI 771716 aims to address this gap with its potential to penetrate all retinal layers more effectively, providing unprecedented efficacy in preserving vision.

Heiko Niessen, Ph.D., from Boehringer Ingelheim, emphasized the significance of this milestone, underscoring the company’s commitment to advancing retinal health. Christian Leisner, Ph.D., from CDR-Life, also highlighted the success of their partnership, reflecting optimism about future clinical benefits. Charles C. Wykoff, MD, Ph.D., the Principal Investigator of the trial, acknowledged the importance of this development in meeting the urgent need for effective GA therapies.

The collaboration between Boehringer Ingelheim and CDR-Life, which began with a licensing agreement in May 2020, continues to make strides, with all milestones achieved to date. The ongoing Phase II study will further evaluate the efficacy and dosing of this innovative therapy.

Notes to Editors:

About the trial (NCT06006585) Study Record | ClinicalTrials.gov

The Phase I trial measured the safety, tolerability, and pharmacokinetics of intravitreal single rising doses and multiple doses of BI 771716 in patients with geographic atrophy aged 50+. The purpose of the study was to determine how well different doses of BI 771716 are tolerated.

This study had two parts.

Single rising dose (SRD)

Participants received one injection of BI 771716 directly into one of the eyes affected by geographic atrophy. The primary endpoint was the number of patients with ocular dose-limiting events (DLEs) from drug administration until Day 8; secondary endpoints included occurrence of any ocular adverse events (AEs) and maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax).

Multiple dose (MD)

Participants received two injections of BI 771716 directly into the eye. There were 4 weeks between the first and the second injection.

Detailed study results will be made available in the coming months.

About BI 771716

BI 771716, developed by Boehringer Ingelheim with technology licensed from CDR-Life, is a highly specific antibody fragment, enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology. BI 771716 is part of Boehringer Ingelheim’s research and development portfolio in retinal conditions.

About Geographic Atrophy (AMD)

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.4 Geographic atrophy (GA) is an advanced and severe form of AMD that progresses slowly but can lead to permanent vision loss.4 More than 5 million people worldwide suffer from GA, of which more than 40% are legally blind.1-3 From age 50 years, the prevalence of GA quadruples every 10 years.5 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.4 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.4

About Boehringer Ingelheim

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com.

About CDR-Life

CDR-Life is developing powerful T-cell engagers (TCE) to eradicate hard-to-treat solid tumors. Our integrated antibody-based TCE platform unlocks access to a wide range of cancer antigens. We are leveraging this platform to advance a pipeline of potent and selective TCE therapeutics targeting intracellular and surface tumor antigens. With a team of proven drug development experts and backed by leading cross-Atlantic investors, we are working to empower patients’ own immune systems to eliminate tumors.

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

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.
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.
Colijn JM et al. Enlargement of Geographic Atrophy From First Diagnosis to End of Life. JAMA Ophthalmol. 2021;139(7):743-750
Sacconi R, et al. A Review of Current and Future Management of Geographic Atrophy. Ophthalmol Ther 2017;6:69-77.
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

Media Contacts :

Boehringer Ingelheim:
Dr. Reinhard Malin
Boehringer Ingelheim
Corporate Affairs
press@boehringer-ingelheim.com

CDR-Life: 
Lauren Arnold
LA Communications
Lauren@LACommunications.net

SOURCE: Boehringer Ingelheim

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