Breye raises €67.5M for diabetic eye disease trial with Novo Holdings backing

Why it matters: The Series A round positions Breye to generate clinical proof-of-concept data on a drug candidate that could change how physicians treat non-proliferative diabetic retinopathy (NPDR). Breye’s lead program, danegaptide, is an oral challenger for a market dominated by therapies that are injected into the eye.

• Bayer, Novartis and Roche have European Union approvals for intravitreally injected therapies that neutralize VEGF to treat eye diseases. 
• However, researchers see a need for more convenient treatments, leading Breye to take its oral drug candidate through a Phase 1b trial that generated early signs of clinical activity.

What they’re saying: “Despite the efficacy of [intravitreal VEGF-neutralizing agents], the invasive nature and short interval between injections have not yielded widespread adoption in patients with NPDR,” said the authors of a recent Science Translational Medicine paper on danegaptide.

Zoom in: New backer Mission BioCapital and existing investor Novo Holdings co-led the Series A round. 

• Existing investor Sound Bioventures participated in the round, as did new backers including the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures and Pappas Capital.
• Robert Blazej, partner at Mission BioCapital, and Lukas Ljungström from the Ljungström family office will join Breye’s board.

How it works: Danegaptide is a small therapeutic peptide designed to maintain gap junction intercellular coupling under stressed conditions. Applied to NPDR, the mechanism of action could protect patients against retinal capillary loss and vascular leakage.

Backstory: Wyeth began a Phase 1 trial of danegaptide, then called GAP-134, in 2007. The drugmaker, which Pfizer acquired for $68 billion (€60 billion) in 2009, developed the drug candidate under its partnership with Denmark’s Zealand Pharma.

• Zealand Pharma completed a Phase 2 trial of danegaptide in heart attack patients in 2016. The study missed its primary endpoint. 
• Later, Zealand Pharma researchers published preclinical evidence that danegaptide may inhibit cell death and excess vascular permeability in diabetic retinopathy.
• In 2022, Novo Holdings and Sound Bioventures launched Breye with €4 million in seed funding. Breye in-licensed danegaptide from Zealand and appointed Ulrik Mouritzen, previously Zealand’s head of clinical development, as CEO.

What’s next: Breye plans to start a randomized Phase 2 trial in NPDR next year. It will be the first substantial test of whether danegaptide’s early clinical signals translate into a benefit for patients.