Breye Therapeutics’ oral small molecule for non-proliferative diabetic retinopathy (NPDR) has demonstrated safety and early signs of improving disease activity in an early-stage trial.
In the Phase Ib study, Breye’s lead candidate, danegaptide, demonstrated early effectiveness, with more than half of the patients showing retinal imaging data associated with reductions in vascular leakage and several patients achieved noteworthy anatomical improvements after four weeks.
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By the end of the study, a statistically significant reduction in oedema measures was observed. The study evaluated the drug in patients with NPDR and associated diabetic macular oedema (DME), a complication of NPDR.
In the trial, danegaptide presented a favourable safety profile, with plasma levels within the targeted therapeutic range.
Data from the Phase Ib trial were presented at the prestigious Angiogenesis, Exudation, and Degeneration 2026 symposium.
Professor Carl Regillo, director of Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia, and member of the Breye Therapeutics Scientific Advisory Board, said: “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.”
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By GlobalDataBased on the data, Breye is now planning a randomised, Phase II trial to further evaluate danegaptide in NPDR patients.
Danegaptide is an oral small molecule with a novel mechanism of action. It acts by stabilising the vasculature and protects against cell-cell uncoupling, retinal capillary breakdown and vascular leakage caused by hyperglycaemia.
The standard of care for patients with NDPR is intravitreal (IVT) injections, with most being prescribed to treat advanced stages of disease, including proliferative diabetic retinopathy (PDR), DME, and neovascular age-related macular degeneration (nAMD).
One drug that has had a significant impact on treating NDPR, DME and PDR patients, amongst other retinopathy diseases, is Regeneron’s Eylea (aflibercept). US sales peaked in 2022, reaching $6.3bn, with generics eroding sales since. The company has also produced Eylea HD, which allows for less frequent dosing.
An oral medication provides patients who struggle with IVT injections an alternative method of treatment.
