Danish biopharmaceutical company Breye Therapeutics recently initiated a clinical trial to investigate danegaptide, following oral administration, in patients suffering from diabetic macular edema (DME). The study’s design is a multicenter, open-label, dose-escalating phase 1b/2a study to assess the safety, tolerability, pharmacokinetics (PK), and early signs of biological activity following oral administration of danegaptide in participants diagnosed with DME.

As an oral therapy, danegaptide targets the core pathological events in DR, including cell-cell uncoupling, apoptotic vascular cell death, and vascular leakage, at earlier stages of disease progression. The company says that safety data derived from over 500 previous clinical trial participants, as well as nonclinical in vitro and in vivo efficacy results, provide strong support for danegaptide's potential to address the clinical core ocular pathologies of vascular leakage and capillary breakdown.

“The launch of the 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, said Brye Therapeutics Chief Executive Officer Ulrik Mouritzen.

“Danegaptide has the potential to become a valuable oral treatment option for patients with diabetic retinopathy,” said Carl Regillo, MD, director of the Retina Service of Wills Eye Hospital and professor of ophthalmology at Thomas Jefferson University in Philadelphia. “Patients should ideally be treated earlier and before the disease progresses to later stages, where laser treatments or intravitreally administered products are required.” Dr. Regillo is a member of the Breye Therapeutics Scientific Advisory Board. NRP