Breye Therapeutics has raised €67.5 million in an oversubscribed Series A financing round to advance its lead candidate, danegaptide, into a Phase II clinical trial for non-proliferative diabetic retinopathy (NPDR).
The round was co-led by Mission BioCapital and existing investor Novo Holdings, with participation from Sound Bioventures and new investors including the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures, and Pappas Capital.
Breye plans to use the funding to initiate a randomized Phase II study of danegaptide in patients with NPDR in 2027, with the aim of clinical proof-of-concept.
Danegaptide is an oral small molecule designed to stabilize the retinal vasculature and protect against capillary breakdown and vascular leakage associated with chronic hyperglycemia. According to Breye, the candidate represents a potentially non-invasive approach to treating diabetic retinopathy at an earlier stage of disease.
The company completed a Phase Ib study of danegaptide in patients with NPDR in 2025. Breye reported that the therapy was well tolerated across all dose levels and showed early signs of clinical activity, including retinal imaging findings consistent with reduced vascular leakage.
The development program targets an area where treatment options remain limited. Although intravitreal therapies are available for more advanced diabetic retinal disease, their administration requires injections into the eye. Breye is developing danegaptide as an oral option that could potentially be used earlier in the disease course and alongside existing therapies.
“Importantly, [the financing] enables us to advance danegaptide, our pioneering, first-in-class oral treatment for diabetic retinopathy, to the next stage of clinical development – bringing a much-needed patient-friendly treatment option closer to those living with this debilitating eye disease,” said Ulrik Mouritzen, CEO of Breye Therapeutics.
The financing will also support Breye’s wider ophthalmology pipeline, including an oral P2X7 receptor antagonist for intermediate age-related macular degeneration, which is being developed to target inflammation and nerve damage. The company is also advancing neuroprotective candidates for glaucoma toward IND-enabling studies.
As part of the financing, Robert Blazej of Mission BioCapital and Lukas Ljungström will join Breye’s board. Of Mission BioCapital’s role as a new investor, Blazej said: “We are excited to support the company at this pivotal stage of growth. With its highly differentiated approach, clear development strategy and experienced team, we believe Breye is uniquely positioned to address a significant unmet need in diabetic retinopathy.”
Source: Breye Therapeutics.
