Breye Therapeutics has raised an oversubscribed €67.5 million Series A financing to advance its lead retinal disease candidate danegaptide into a randomized Phase 2 clinical trial. The round was co-led by new investor Mission BioCapital and existing investor Novo Holdings.
Existing investor Sound Bioventures also participated, along with new investors the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures and Pappas Capital.
Breye plans to use the financing primarily to advance danegaptide in patients with non-proliferative diabetic retinopathy, or NPDR.
The Phase 2 study is expected to begin in 2027 and is intended to demonstrate clinical proof of concept.
Danegaptide is a first-in-class oral small molecule designed to stabilize retinal vasculature and protect against capillary breakdown and vascular leakage associated with chronically high glucose levels.
A Phase 1b study in NPDR patients showed the drug was well tolerated across all dose levels and produced early signs of clinical activity, including retinal imaging data consistent with reduced vascular leakage.
Breye estimates that diabetic retinopathy affects approximately 130 million people globally and noted that treatment options remain limited for patients with early or moderate-stage NPDR.
The company is developing an oral approach that could complement existing intravitreal therapies, which require injections directly into the eye.
Part of the Series A proceeds will also support Breye’s broader pipeline, including a P2X7 receptor antagonist for intermediate age-related macular degeneration and neuroprotective candidates for glaucoma.
Robert Blazej of Mission BioCapital and Lukas Ljungström of the Ljungström family office will join Breye’s board as part of the financing.
KEY QUOTES:
“This €67.5m Series A financing, which includes significant support from both new and existing investors, reflects the strong confidence in Breye’s vision, strategy, and pipeline. It marks a major milestone for the Company and validates the enormous progress we have made to date. Importantly, it 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.”
Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics
“Breye is emerging as a leader in the development of innovative retinal disease therapies, as demonstrated by the promising results from its recent Phase Ib study of danegaptide, and 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.”
Robert Blazej, Partner at Mission BioCapital
“Danegaptide has the potential to address a major unmet need in diabetic retinopathy, by offering what we believe will be a highly effective, non-invasive treatment solution. Our continued investment in Breye Therapeutics reflects the strong progress the Company has made and our confidence in the team. Breye is purposefully advancing its mission of delivering innovative therapies for patients with retinal eye diseases, who have very limited treatment options, and we are very proud to continue to support the team.”
Jørgen Søberg Petersen, Senior Partner at Novo Holdings
