- Prof. Carl D. Regillo, MD, presented clinical data from the Phase 1b trial evaluating Breye Therapeutics’ lead candidate, danegaptide, in 24 patients with non-proliferative diabetic retinopathy (NPDR) with associated macular edema
- Oral treatment was well tolerated, showed signs of clinical effect and retinal imaging data consistent with reductions in vascular leakage, one of the core pathologies of NPDR
- Reductions in vascular leakage are well-known to precede reductions in Diabetic Retinopathy Severity Scale (DRSS) scores
- The data support initiation of a Phase 2, randomized clinical trial in patients with NPDR to assess reductions in DRSS scores, which Breye Therapeutics is currently preparing for
COPENHAGEN, Denmark, Feb. 09, 2026 (GLOBE NEWSWIRE) -- Breye Therapeutics ApS (Breye), a clinical-stage ophthalmology-focused biopharmaceutical company developing oral therapeutics for the early treatment of retinal diseases, today announces clinical data showcasing the potential of its lead candidate, danegaptide, was presented at the prestigious Angiogenesis, Exudation, and Degeneration 2026 symposium on 7 February 2026.
Danegaptide is a first-in-class oral small molecule with a novel mode of action, that stabilizes the vasculature and protects against cell-cell uncoupling, retinal capillary breakdown and vascular leakage caused by hyperglycemia. Conducted across 11 clinical sites in the UK, Germany and the US, the Phase 1b study was a multi-center, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics (PK) and early signs of biological activity of danegaptide in patients with NPDR and associated diabetic macular edema (DME), a complication of NPDR.
The data confirmed a favorable safety profile, with plasma levels within the targeted therapeutic range – and demonstrated early signs of clinical activity. Importantly, more than half of the patients showed retinal imaging data associated with reductions in vascular leakage and several patients achieved noteworthy anatomical improvements following the 4-week treatment period. By the end of the study, a statistically significant reduction in edema measures was observed. Based on these encouraging data, a randomized Phase 2 trial is planned to evaluate danegaptide in the targeted NPDR patient population, using the regulatory endpoint of improvements on the Diabetic Retinopathy Severity Scale (DRSS) score. Breye is actively fundraising to support this next phase of development.
Prof. Carl Regillo, MD, Director of Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia, Member of the Breye Therapeutics Scientific Advisory Board, commented: “The clinical data are encouraging and support the pursuit of danegaptide as an oral, non-invasive treatment solution. Danegaptide has the potential to be a medicine capable of treating diabetic retinopathy from its earlier, NPDR stages. This would create new options for how diabetic retinopathy is treated – opening the door to halting or even reversing disease and treating it before the risk emerges of disease progression to advanced forms. As an oral therapy, it would enable treatment intervention earlier than what is possible today.”
Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, said: “Breye is building the first oral, disease-modifying therapies that can stop and reverse vision-threatening damage, with a clear, de-risked path to Phase 3 for the lead asset danegaptide. Diabetic retinopathy is a large and growing problem, but AI is revolutionizing our ability to identify the disease at its earlier stages. Finding more early-stage patients in need of therapy will drive the need for better and earlier treatment solutions.”
Currently, intravitreal (IVT) injections are the mainstay treatment for patients with severe retinal diseases caused by leaky blood vessels in the eye and with clinical symptoms of visual loss. Most injections are prescribed to treat advanced stages of disease, including proliferative diabetic retinopathy (PDR), diabetic macular edema (DME), and neovascular age-related macular degeneration (nAMD). However, the in-office IVT injection procedures are increasingly burdensome for patients and their caregivers, and resource demanding for clinical practices. The healthcare systems are continuously needing to adapt to accommodate increasing demand. Many patients also find repeated IVT injections burdensome, contributing to high discontinuation rates and thus less optimal outcomes. Orally administered medications and IVT administered therapies would work in concert and help reaching a broader spectrum of patients in need.
Diabetic retinopathy is a leading cause of vision loss among working-age adults, affecting millions of people with diabetes. While IVT can help preserve vision in patients with late-stage disease, treatment options are currently very limited for patients with early or moderate-stage disease, before loss of visual function, representing the majority of patients who remain currently untreated, despite diagnosed diabetic retinal disease. Intravitreal treatments are often poorly tolerated and associated with low continued adherence, highlighting the critical need for effective non-invasive alternatives. An oral, non-invasive treatment solution would therefore make a real difference to patients and to healthcare providers – ultimately helping to preserve vision.
For further information:
Optimum Strategic Communications
Mary Clark, Vici Rabbetts, Aoife Minihan
Tel: +44 20 3922 1906
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
