Breye Initiates Oral Dosing of Danegaptide in Phase 1b/2a Clinical Trial for DME

Breye Therapeutics ApS (Breye), a leading clinical-stage biopharmaceutical company specializing in novel oral therapies for retinal vascular diseases, has commenced a phase 1b/2a clinical trial to explore the potential of danegaptide, administered orally, in patients with diabetic macular edema (DME).

The trial marks a significant step forward in Breye's mission to develop more effective and globally accessible orally administered treatment solutions for patients at risk of vision loss and blindness due to Diabetic Retinopathy (DR) or Age-Related Macular Degeneration (AMD). While intravitreally administered products have proven successful for late-stage disease, current treatment options for patients in the early or moderate stages remain limited.

Danegaptide, as an oral therapy, targets the core pathological events in DR at earlier stages of disease progression, including cell-cell uncoupling, apoptotic vascular cell death, and vascular leakage.

Backed by safety data from over 500 clinical trial participants, robust toxicology data, and compelling non-clinical in vitro and in vivo efficacy results, danegaptide demonstrates significant potential in addressing the clinical core ocular pathologies of vascular leakage and capillary breakdown, with positive effects clinically validated.

The phase 1b/2a study is designed as a multicenter, open-label, dose-escalating trial to evaluate the safety, tolerability, pharmacokinetics (PK), and early signs of biological activity following oral administration of danegaptide in participants diagnosed with DME.

Ulrik Mouritzen, CEO of Breye Therapeutics, expressed the significance of the Phase 1b/2a clinical trial, stating, “The launch of the Phase 1b/2a clinical trial for danegaptide represents a significant milestone towards realizing our mission of developing more effective, globally accessible orally administered treatment solutions for patients at risk of vision loss and blindness.”

Prof. Carl Regillo, MD, Director of Retina Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University, and a Member of the Breye Therapeutics Scientific Advisory Board, highlighted the potential of danegaptide as a valuable oral treatment option for patients with Diabetic Retinopathy. He emphasized the importance of early intervention to prevent disease progression to later stages, where more invasive treatments become necessary.