Breye Raises EUR 67.5M Series A to Take Oral Danegaptide Into Phase II Diabetic Retinopathy Trial
核心洞察
Breye Therapeutics (搜索) raised EUR 67.5 million in an oversubscribed Series A co-led by Mission BioCapital (搜索) and Novo Holdings (搜索) to fund a Phase II trial of oral danegaptide in non-proliferative diabetic retinopathy (搜索).
The randomized Phase II study is expected to begin in 2027 and will assess clinical proof-of-concept using improvement on the Diabetic Retinopathy Severity Scale.
A completed Phase Ib trial in 24 NPDR patients with macular edema found danegaptide well tolerated with retinal imaging changes consistent with reduced vascular leakage.
Breye Therapeutics (搜索) ApS has raised EUR 67.5 million in an oversubscribed Series A financing to advance its oral small molecule danegaptide into a randomized Phase II trial in non-proliferative diabetic retinopathy (搜索) (NPDR). The Denmark-based company said the round was co-led by new backer Mission BioCapital (搜索) and existing investor Novo Holdings (搜索).
The financing also drew participation from existing investor Sound Bioventures (搜索) and new investors including the Ljungström family office, Innovestor Life Science, EIFO, Catalyze Capital, Modi Ventures and Pappas Capital. Robert Blazej, partner at Mission BioCapital (搜索), and Lukas Ljungström from the Ljungström family office will join Breye's board.
Proceeds will fund the Phase II study, which is expected to begin in 2027, along with continued development of the company's broader oral retinal-disease pipeline.
Phase II Design and Proof-of-Concept Goal
Breye is planning the randomized Phase II trial to assess clinical proof-of-concept using improvement on the Diabetic Retinopathy Severity Scale. The study follows a completed Phase Ib trial in 24 patients with NPDR and associated macular edema, in which danegaptide was well tolerated and showed early signs of clinical activity, including retinal imaging changes consistent with reduced vascular leakage.
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, stabilizing the retinal vasculature and reducing capillary breakdown.
An Oral Challenger to Intravitreal Injections
Breye's lead program is positioned as an oral alternative in a market dominated by therapies injected into the eye. Bayer, Novartis and Roche hold European Union approvals for intravitreally injected therapies that neutralize VEGF to treat eye diseases, but researchers see a need for more convenient treatments.
"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," the authors of a recent Science Translational Medicine paper on danegaptide wrote.
From GAP-134 to Breye
Danegaptide has a long development history. Wyeth began a Phase 1 trial of the compound, then called GAP-134, in 2007, developing it under a partnership with Denmark's Zealand Pharma. Pfizer acquired Wyeth for $68 billion (EUR 60 billion) in 2009. Zealand Pharma (搜索) completed a Phase 2 trial of danegaptide in heart attack patients in 2016; that study missed its primary endpoint. Zealand researchers later published preclinical evidence that danegaptide may inhibit cell death and excess vascular permeability in diabetic retinopathy.
Novo Holdings (搜索) and Sound Bioventures (搜索) launched Breye in 2022 with EUR 4 million in seed funding. The company in-licensed danegaptide from Zealand and appointed Ulrik Mouritzen, previously Zealand's head of clinical development, as CEO.
Broader Retinal Pipeline
Beyond danegaptide, Breye is developing oral P2X7 receptor (搜索) antagonists for intermediate age-related macular degeneration (搜索) and additional neuroprotective candidates for glaucoma (搜索).