- Oral treatment danegaptide represents “a potential paradigm shift” toward earlier, non-invasive treatment of Non-Proliferative Diabetic Retinopathy (NPDR), say authors
- Study “provides compelling evidence” that danegaptide robustly protects inner blood-retina barrier (iBRB), while also dampening VEGF-associated activity
- This “dual approach”, and its ability to be used earlier, “may translate into improved outcomes”
- Breye is now planning a Phase II proof-of-concept trial of danegaptide in a targeted NPDR population, due to start in 2027
COPENHAGEN, Denmark, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Breye Therapeutics ApS (Breye), a clinical-stage biopharmaceutical company developing oral therapeutics for the early treatment of retinal diseases, today announces that it has had an academic paper on its lead asset danegaptide published in the prestigious journal Science Translational Medicine (STM).
Danegaptide is a first-in-class oral small molecule with a novel mode of action that stabilizes the retinal vasculature, thus protecting against retinal capillary breakdown and vascular leakage caused by chronically high glucose levels (hyperglycemia).
Led by Professor Matthew Campbell of Trinity College Dublin, an internationally recognized expert on vascular barrier biology, the paper analyzes pre-clinical and early clinical-stage (Phase 1b) data to describe how danegaptide protects against the disease’s underlying pathology, and its potential as a patient-friendly oral therapy which could be used to treat NPDR much earlier in the course of disease than currently approved treatment – thereby preserving sight. Diabetic retinopathy is a leading cause of vision loss among working-age adults, and today affects about 130 million people worldwide. Incidence is growing rapidly.
Dr Pete Adamson, Chief Scientific Officer, Breye Therapeutics, said: “The data from this study validates a major paradigm shift in retinal care. By proving that an oral therapy like danegaptide can directly protect the inner blood-retina barrier (iBRB), we are opening the door to early, non-invasive intervention for NPDR. The successful Phase Ib results provide a very strong foundation for larger Phase II clinical trials to evaluate long-term efficacy.”
Professor Matthew Campbell, Chair of Neurovascular Genetics at Trinity College Dublin and senior author on the paper, said: “Managing diabetic eye disease before irreversible damage occurs has long been constrained by the burden of invasive injections. Our findings demonstrate that an oral pill can effectively target and repair the inner blood-retina barrier. This potentially offers a non-invasive, preventive path forward that could protect vision in both eyes simultaneously long before severe sight loss takes hold."
Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, said: “We think danegaptide holds immense promise as a complementary treatment solution to currently available options, which, thanks to the fact it is delivered orally, has the potential to greatly increase the number of patients around the world who are able to access therapy for NPDR.”
While current standard-of-care anti-VEGF treatments are effective at arresting the progression of “severe” NPDR, and reducing the risk of associated vision loss, most patients are only offered them after vision loss- has occurred, the authors note in the paper. Furthermore, because they are administered by regular, invasive intravitreal (IVT) injections – directly into the eye – patients find them burdensome, which greatly affects compliance and has contributed to IVT therapies not being broadly adopted in patients with NPDR. An oral, non-invasive treatment solution would be complementary to existing therapies, enabling more patients to be helped around the world.
The authors conclude: “Danegaptide represents a promising paradigm shift toward systemic, non-invasive therapy for chronic retinal vascular disease, addressing both efficacy and patient quality-of-life considerations.”
They add that the pre-clinical and clinical work conducted to date “provides compelling evidence that danegaptide exerts a robust protective effect on the iBRB [inner blood-retinal barrier], reduces pathological retinal vascular leakage, and mitigates retinal edema”.
Publication of the paper comes as Breye plans a randomized Phase 2 clinical trial of danegaptide in patients with NPDR, to demonstrate clinical proof-of-concept, due to start in 2027.
For further information:
Optimum Strategic Communications
Mary Clark, Stephen Adams, Aoife Minihan
Tel: +44 20 3821 6420
Email: breye@optimumcomms.com
About Breye Therapeutics
Breye Therapeutics is a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of retinal eye diseases. Breye is developing a pipeline of oral therapies for diseases of the eye, such as intermediate age-related macular degeneration and glaucoma, so more patients can maintain their sight, autonomy, and quality of life. Its lead candidate, danegaptide, is the first oral drug designed to treat diabetic retinopathy in its earlier stages and has a novel mechanism of action designed to stop and reverse disease progression. It is currently progressing through clinical development, with Phase 1b successfully completed and a Phase 2 trial planned to demonstrate clinical proof-of-concept.
Breye is backed by Novo Holdings and Sound BioVentures, and has received financial support from the BioInnovation Institute, the Danish Growth Foundation (Vækstfonden), and the Danish Innovation Foundation (Innovationsfonden).
For more information, please visit: https://breye.com
