Breye Therapeutics has announced the successful completion of its Phase 1b clinical trial evaluating danegaptide.

This is a first-in-class oral therapy, in patients with non-proliferative diabetic retinopathy (NPDR) and associated edema. The trial met its key objectives, demonstrating that danegaptide was well tolerated with no dose-limiting toxicities, and showed encouraging early signs of clinical activity.

Diabetic retinopathy remains a leading global cause of vision loss, particularly in people with diabetes. While injected (intravitreally administered) treatments have been developed for late-stage disease, these options can be burdensome and poorly tolerated. There are currently limited non-invasive therapies available for earlier-stage patients, leaving a critical unmet need.

Danegaptide, an oral small molecule with a novel mode of action, aims to protect the retina from hyperglycemia-induced vascular damage. In this multicenter, open-label, dose-escalation trial conducted across the UK, Germany, and the US, the candidate achieved targeted therapeutic plasma levels and delivered signs of reduced retinal vascular leakage and anatomical improvement in retinal imaging outcomes.

Ulrik Mouritzen, CEO of Breye Therapeutics, said: “These findings support danegaptide’s potential as a non-invasive treatment that intervenes before irreversible damage sets in. As we prepare for Phase 2, our goal is to confirm these results using regulatory-accepted clinical endpoints.”

The next-stage trial will focus on patients with NPDR and evaluate whether danegaptide can deliver a ≥2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS). Breye is actively raising funds to support the Phase 2 programme.