Breye Therapeutics has presented Phase 1b clinical data for its lead oral candidate danegaptide in patients with non-proliferative diabetic retinopathy, supporting plans to advance the asset into a randomized Phase 2 trial.

The data were presented at the Angiogenesis, Exudation and Degeneration 2026 symposium and come from a multi-centre, open-label, dose-escalation study evaluating danegaptide in 24 patients with non-proliferative diabetic retinopathy with associated diabetic macular edema.

Danegaptide is an oral small molecule designed to stabilise the retinal vasculature and reduce vascular leakage, a central pathological feature of diabetic retinopathy. The Phase 1b trial was conducted across 11 clinical sites in the UK, Germany and the US, and assessed safety, tolerability, pharmacokinetics and early signs of biological activity following four weeks of treatment.

According to the company, danegaptide was well tolerated and achieved plasma concentrations within the targeted therapeutic range. Retinal imaging showed signs consistent with reductions in vascular leakage in more than half of treated patients, alongside anatomical improvements in several individuals. By the end of the treatment period, the study recorded a statistically significant reduction in edema measures.

Reductions in vascular leakage are widely understood to precede improvements in Diabetic Retinopathy Severity Scale scores, a regulatory endpoint commonly used in later-stage diabetic retinopathy trials. Based on the Phase 1b findings, Breye said it is preparing a randomized Phase 2 clinical trial in patients with non-proliferative diabetic retinopathy to evaluate effects on Diabetic Retinopathy Severity Scale outcomes.

Carl Regillo, retina specialist at Wills Eye Hospital and member of Breye Therapeutics’ scientific advisory board, said the data support further clinical development of the oral approach. “The clinical data are encouraging and support the pursuit of danegaptide as an oral, non-invasive treatment solution,” Regillo said. “Danegaptide has the potential to be a medicine capable of treating diabetic retinopathy from its earlier, NPDR stages.”

He added that earlier intervention could change how patients are managed. “As an oral therapy, it would enable treatment intervention earlier than what is possible today,” Regillo said.

Ulrik Mouritzen, ceo of Breye Therapeutics, said the company sees danegaptide as a potential disease-modifying option for retinal disease. “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,” Mouritzen said.

Current treatment for diabetic retinopathy and related retinal diseases relies heavily on intravitreal injections, particularly in later stages such as proliferative diabetic retinopathy, diabetic macular edema and neovascular age-related macular degeneration. These procedures are typically delivered in clinic settings and require repeated administration, placing a burden on patients, caregivers and healthcare systems.

Breye said orally administered therapies could complement intravitreal approaches by enabling treatment earlier in the disease course, before visual function is affected. The company noted that many patients with early or moderate diabetic retinopathy remain untreated despite diagnosis, highlighting an unmet clinical need for non-invasive options.

Diabetic retinopathy remains a leading cause of vision loss among working-age adults globally. Breye said it is actively fundraising to support the planned Phase 2 study of danegaptide.