Breye raises €67.5m with US backing for oral retinal disease treatments
US investor Mission BioCapital co-leads the Danish biotech’s Series A as it prepares a Phase 2 trial of its lead diabetic retinopathy candidate in 2027.
Denmark’s Breye Therapeutics has closed an oversubscribed €67.5 million Series A financing co-led by US investor Mission BioCapital and existing backer Novo Holdings, funding the next clinical test of an oral treatment for diabetic eye disease.
The clinical-stage biotech plans to start a randomised Phase 2 trial of its lead candidate, danegaptide, in 2027. The study will seek clinical proof of concept in patients with non-proliferative diabetic retinopathy, or NPDR, a condition for which Breye sees an opportunity to intervene earlier than existing injected treatments.
The US connection is financial and strategic rather than a disclosed operational expansion. Mission BioCapital is joining the shareholder base, and its partner Robert Blazej will take a board seat. The financing reports do not identify a US office, hiring programme or trial location.
US capital joins a Danish-backed programme
Existing investor Sound Bioventures also participated, alongside new investors including the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures and Pappas Capital. Lukas Ljungström will join the board alongside Blazej.
Founded in 2019, Breye emerged from stealth in November 2022 after securing €4 million in seed funding led by Novo Holdings and Sound Bioventures. The new round substantially increases the capital available to move its Danish-origin drug programme into a larger clinical study.
Chief executive Ulrik Mouritzen has more than 20 years of research and development, regulatory and commercial experience in Europe and the US. He previously headed clinical development at Zealand Pharma, from which Breye in-licensed danegaptide.
For Breye, the significance of the American investment is that it helps finance the evidence needed to establish whether an oral approach can deliver a meaningful patient benefit. It does not, by itself, establish a US market-entry timetable or regulatory pathway.
An oral alternative to injections
Breye is targeting a treatment gap in early- and moderate-stage NPDR. According to the company, current therapies injected directly into the eye can preserve vision in late-stage disease, but their invasive delivery can limit tolerability and continued adherence.
The competitive backdrop includes established pharmaceutical groups. European Biotechnology Magazine notes that Bayer, Novartis and Roche have European Union approvals for injected therapies that neutralise vascular endothelial growth factor, or VEGF, to treat eye diseases. Breye’s proposed differentiation is an oral treatment aimed at protecting retinal blood vessels earlier in the disease course—not a demonstrated replacement for those products.
Danegaptide is designed to protect against retinal capillary breakdown and vascular leakage associated with chronically high blood glucose. Breye reported that its completed Phase 1b trial found the candidate well tolerated across all dose levels, with early signs of activity, including imaging findings consistent with reduced vascular leakage. Those signals are preliminary; the planned Phase 2 study is intended to test clinical proof of concept.
Breye puts the global population affected by diabetic retinopathy at about 130 million and estimates the therapeutic market is approaching €8.8 billion, or $10 billion. These are company-cited global figures, not estimates of the US opportunity alone.
A repurposed asset, with clinical risk ahead
Danegaptide has a development history beyond ophthalmology. Zealand completed a Phase 2 trial in heart attack patients in 2016 that missed its primary endpoint. Researchers subsequently published preclinical evidence suggesting potential benefits in diabetic retinopathy. The earlier cardiovascular result is part of the asset’s history, but does not establish its effectiveness in retinal disease.
The Series A will also support Breye’s broader oral pipeline: a P2X7 receptor antagonist for intermediate age-related macular degeneration and glaucoma candidates with intended neuroprotective effects. Those programmes are advancing towards IND-enabling studies. For now, the key milestone is the 2027 danegaptide trial—a test of whether fresh transatlantic backing can help turn early clinical signals into stronger evidence.
