Breye Therapeutics (Breye), a Danish clinical-stage biopharmaceutical company developing oral therapeutics for the early treatment of retinal diseases, has closed an oversubscribed €67.5 million Series A financing round.
The round was co-led by new investor Mission BioCapital and existing investor Novo Holdings, with participation from existing investor Sound Bioventures and additional new investors, including the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures and Pappas Capital. Together with this financing, Robert Blazej, Partner at Mission BioCapital, and Lukas Ljungström from the Ljungström family office will join Breye’s board.
Ulrik Mouritzen, Chief Executive Officer, Breye Therapeutics, said, “This €67.5 million 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.”
Breye was founded in 2019 and emerged from stealth in November 2022 after closing a €4 million Seed round led by Novo Holdings and Sound Bioventures. Mouritzen, an M.D. and industry veteran with more than 20 years of R&D, regulatory, and commercial experience in Europe and the US, leads the company.
It is developing a pipeline of oral therapies for eye diseases, such as intermediate age-related macular degeneration and glaucoma. According to the company, diabetic retinopathy is a leading cause of vision loss among working-age adults, affecting about 130 million people worldwide today. It also highlighted that the current market value of diabetic retinopathy therapeutics is approaching €8.8 billion ($10 billion), and could nearly double over the next decade, with a predicted CAGR of 6.5%.
“While currently available intravitreal (IVT) treatments can help preserve vision in patients with late-stage disease, their invasive nature – being injected directly into the eye – means they are often poorly tolerated and associated with low continued adherence. In addition, treatment options for patients with early- or moderate-stage Non-Proliferative Diabetic Retinopathy (NPDR) remain very limited,” the company mentioned in the press release.
It opines that this unmet medical need, coupled with a growing patient population, highlights the substantial market opportunity for danegaptide.
Danegaptide is the company’s lead candidate and a first-in-class oral small molecule with a novel mechanism of action that stabilises retinal vasculature, protecting against retinal capillary breakdown and vascular leakage caused by chronically high glucose levels (hyperglycemia).
Breye reports that the financing follows the successful completion of a Phase 1b trial in patients with NPDR last year, which showed danegaptide was well tolerated across all dose levels and exhibited early signs of clinical activity, including retinal imaging data consistent with reductions in vascular leakage, one of the core pathologies of NPDR.
Recently, Breye also published an academic paper analysing the pre-clinical and early clinical-stage evidence for danegaptide in the prestigious journal Science Translational Medicine.
Robert Blazej, Partner, Mission BioCapital, said, “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.”
The company plans to use this capital to advance Breye’s lead asset danegaptide into a randomised Phase 2 clinical trial in patients with NPDR. The study, which aims to demonstrate clinical proof of concept, is due to start in 2027.
The funding will also support the company’s broader pipeline of oral small molecules, including a P2X7 receptor antagonist for iAMD intended to reduce nerve damage and inflammation, and additional glaucoma candidates with neuroprotective effects. These are advancing towards IND-enabling studies.