Breye Therapeutics has reported promising early clinical findings for its lead oral therapy danegaptide, following a presentation at the Angiogenesis, Exudation and Degeneration 2026 symposium.
The data, presented by Prof. Carl Regillo, detailed results from a phase 1b study involving 24 patients with non‑proliferative diabetic retinopathy (NPDR) and associated macular oedema.
The multi‑centre, open‑label trial, conducted across 11 sites in the UK, Germany and the US, assessed safety, tolerability, pharmacokinetics and early biological activity.
Danegaptide is described as a first‑in‑class oral small molecule designed to stabilise the vasculature and protect against retinal capillary breakdown and vascular leakage caused by hyperglycaemia.
According to Breye, the treatment was well tolerated and produced plasma levels within the targeted therapeutic range.
More than half of participants showed retinal imaging data consistent with reductions in vascular leakage, a key pathology in NPDR, and several patients demonstrated notable anatomical improvements after four weeks of treatment. By study end, a statistically significant reduction in oedema measures had been recorded.
These findings support Breye’s plans to initiate a phase 2 randomised clinical trial in NPDR, using improvements in Diabetic Retinopathy Severity Scale scores as the regulatory endpoint. The company is currently preparing for this next stage and is fundraising to support development.
Prof. Regillo 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. As an oral therapy, it would enable treatment intervention earlier than what is possible today.”
