Boehringer Ingelheim to advance potential new treatment for GA following Phase 1 results
BI 771716, with technology licensed from CDR-Life, 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.
(Image credit: AdobeStock/Corona Borealis)
Boehringer Ingelheim and CDR-Life revealed positive results from the Phase I evaluation of BI 771716, an investigational antibody fragment developed to preserve vision in people living with geographic atrophy (GA).
According to the companies, BI 771716 met its primary safety endpoint after an intravitreal administration of single and multiple doses. The companies are now preparing for the Phase II trial, which is expected to start in early 2025.1
GA is an advanced and severe form of late-stage, dry age-related macular degeneration (AMD), a chronic and progressive retinal disease, that can lead to irreversible and permanent vision loss.1 It is a leading cause of blindness, affecting more than 5 million people worldwide, of which more than 40% are considered blind.2-4
Boehringer Ingelheim developed BI 771716 with technology it licensed from CDR-Life. It 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. It features molecular properties that give it the potential to achieve efficacy.1
Heiko Niessen, PhD, Global Therapeutic Area Head Translational Medicine & Clinical Pharmacology Retinal Health at Boehringer Ingelheim, said the company was pleased to advance BI 771716 to the next step of development.
“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,” Niessen said in the news release. “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.”
Christian Leisner, PhD, CEO at CDR-Life, also lauded the achievement.
"Reaching this safety milestone is a significant step forward for this compound, highlighting the strength of our partnership with Boehringer Ingelheim," Leisner said in the news release. "Having successfully met all 4 planned milestones so far, we're optimistic about the continued development of this innovative antibody fragment-based therapy and its potential to provide clinical benefit in geographic atrophy."
Charles C. Wykoff, MD, PhD, a 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, highlighted the importance of the development of therapies like BI 771716.
“The development of new therapies for geographic atrophy remains one of the most important needs in the age-related macular degeneration space,” Wykoff said in the news release. “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.”
CDR-Life and Boehringer Ingelheim announced their collaboration and licensing agreement 4 years ago, followed by the selection of an antibody fragment-based therapeutic candidate 3 years ago. The companies have executed on all milestones to date.
According to the news release, the Phase I trial (NCT06006585) measured the safety, tolerability, and pharmacokinetics of intravitreal single rising doses and multiple doses of BI771716 in patients with geographic atrophy aged 50+. The purpose of the study was to determine how well different doses of BI 771716 are tolerated.1
This study had two parts.
The companies noted that in a single rising dose (SDR), participants received 1 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 from drug administration until Day 8; secondary endpoints included the occurrence of any ocular adverse events (AEs) and maximum serum concentration of BI 771716 after a single intravitreal (IVT) dose (Cmax).
In a multiple-dose (MD), the participants received 2 injections of BI 771716 directly into the eye. There were 4 weeks between the first and the second injection.
References:
Boehringer Ingelheim. Boehringer Ingelheim announces plans to advance potential new treatment for Geographic Atrophy, following positive Phase I results. GlobeNewswire News Room. Published September 5, 2024. Accessed September 6, 2024. https://www.globenewswire.com/news-release/2024/09/05/2941540/0/en/Boehringer-Ingelheim-announces-plans-to-advance-potential-new-treatment-for-Geographic-Atrophy-following-positive-Phase-I-results.html
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
