€67.5m · Series A · Healthtech · Copenhagen, Denmark
Copenhagen-based Breye Therapeutics has raised an oversubscribed €67.5m Series A to move its lead oral treatment for non-proliferative diabetic retinopathy into a randomised Phase 2 trial. Mission BioCapital and existing investor Novo Holdings co-led the round, with Sound Bioventures, the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures and Pappas Capital participating. The company says the trial is due to begin in 2027.
Danegaptide is an oral small molecule intended to stabilise the retinal vasculature against capillary breakdown and leakage caused by chronically high blood glucose. That delivery route matters because current anti-VEGF treatments are injected into the eye and are generally used once disease has progressed. Breye is trying to create an earlier, less invasive option, but the programme has not yet demonstrated efficacy in a controlled Phase 2 study.
The company’s completed Phase 1b trial enrolled 24 patients with non-proliferative diabetic retinopathy and mild centre-involved macular oedema. A peer-reviewed paper in Science Translational Medicine reported no serious adverse events related to oral danegaptide and described early imaging and biological signals alongside preclinical findings. Those results support a larger efficacy trial; they do not establish that the drug prevents sight loss.
The round buys a clinical proof point
Breye plans to use a two-step improvement on the Diabetic Retinopathy Severity Scale as the regulatory endpoint for Phase 2, with a company pipeline page targeting a readout in 2029. The financing therefore has a defined job: fund the move from a small, open-label safety study to a randomised test of whether the mechanism produces a clinically meaningful effect.
The commercial proposition depends on both efficacy and treatment burden. An oral therapy could reach patients earlier and avoid repeated eye injections, but only if later trials show durable benefit and an acceptable safety profile for longer-term systemic dosing. The Phase 2 result is the point at which Breye can begin to separate a convenient delivery format from a medicine with proven clinical value.
Part of the round will also advance Breye’s P2X7 receptor-antagonist programme for intermediate age-related macular degeneration and earlier glaucoma candidates. The company launched in 2022 with €4m from Novo Holdings and Sound Bioventures and in-licensed danegaptide from Zealand Pharma. Mission BioCapital partner Robert Blazej and Lukas Ljungström will join the board alongside the new financing.
