Breye Therapeutics announces successful completion of its Phase 1b trial with danegaptide in patients with diabetic retinopathy

• Orally administered treatment was well tolerated, with early signs of clinical activity
• In models of non-proliferative diabetic retinopathy (NPDR), danegaptide has demonstrated protection against retinal capillary loss and vascular leakage
• Data support continued advancement into Phase 2 clinical evaluation

COPENHAGEN, Denmark, June 24, 2025 /PRNewswire/ -- Breye Therapeutics ApS (Breye), a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases, today announces the successful completion of its Phase 1b clinical trial evaluating its lead candidate, danegaptide, in patients with non-proliferative diabetic retinopathy (NPDR) with associated edema.

Diabetic retinopathy (DR) is a leading cause of vision loss globally, affecting millions of people with diabetes. While there has been successful development of intravitreally administered products, injected directly into the eye, for patients with late-stage disease, treatment options are currently limited for patients in the earlier or moderate stages. The intravitreal treatments are burdensome, often poorly tolerated and associated with low compliance, highlighting the critical need for effective and non-invasive alternatives.

Danegaptide is a first-in-class oral small molecule with a novel mode of action, that stabilizes the vasculature and protects from cell-cell uncoupling, retinal capillary breakdown and vascular leakage caused by hyperglycemia.

The orally administered treatment was well tolerated across all dose levels in the 24 patients enrolled, with no dose-limiting toxicities reported. Pharmacokinetic (PK) data confirmed that targeted exposures of danegaptide were reached as guided by preclinical data. Early signs of clinical activity were observed, as measured by retinal imaging outcomes, representing reductions in retinal vascular leakage and improvements in anatomical parameters.

Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, said: "These results continue to support danegaptide's potential as an oral, non-invasive therapeutic solution for patients in the earlier stages of diabetic retinopathy. As we now prepare to advance into Phase 2 clinical evaluation, our focus is on validating these findings using regulatory-accepted clinical outcomes to progress our mission of developing safe and effective treatment options for these patients to preserve their vision before the onset of irreversible damage. Additionally, we believe this treatment solution may also support the maintenance of treatment response after induction therapy with intravitreally administered products."

Prof. Carl Regillo, MD, Director of Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia, Member of the Breye Therapeutics Scientific Advisory Board, commented: "An oral approach like danegaptide has the potential to fundamentally shift how we treat moderate to severe-stages of diabetic eye disease, offering patients a much-needed and non-invasive treatment solution for the large group of patients with NPDR."

The Phase 1b trial was a multicenter, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics (PK) and early signs of biological activity of danegaptide in patients with NPDR and associated diabetic macular edema (DME), a complication of NPDR. Conducted across 11 clinical sites in the UK, Germany and the US, the study confirmed a favourable safety profile, plasma levels within the targeted therapeutic range and early signs of clinical activity.

A subsequent Phase 2 trial is planned to evaluate danegaptide in a targeted NPDR patient population using the regulatory endpoint of ≥2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS). Breye is actively fundraising to support this next phase of development.

About Breye Therapeutics

Breye Therapeutics is a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases. Breye is developing a pipeline of oral therapies for diseases of the eye, such as intermediate age-related macular degeneration and glaucoma, so more patients can maintain their sight, autonomy, and quality of life. Its lead candidate, danegaptide, is the first oral drug designed to treat diabetic retinopathy in its earlier stages and has a novel mechanism of action designed to stop and reverse disease progression. It is currently progressing through clinical development, with Phase 1b successfully completed and a Phase 2 trial planned to demonstrate clinical proof-of-concept.

Breye is backed by Novo Holdings and Sound BioVentures, and has received financial support from the BioInnovation Institute, the Danish Growth Foundation (Vækstfonden), and the Danish Innovation Foundation (Innovationsfonden).

For more information, please visit: https://breye.com.