Breye Therapeutics ApS (Breye), a leading clinical-stage biopharma company headquartered in Denmark, has initiated a phase 1b/2a clinical trial to check the safety, side effects, and dosage of danegaptide, administered orally, in patients with diabetic macular edema (DME). The company is committed to developing novel, oral ophthalmology drugs for millions of patients suffering from deteriorating vision due to Diabetic Retinopathy (DR). Although intravitreally administered products for patients with late-stage disease are already available in the market, treatment options for the early or moderate stages are currently limited.

Based on the robust toxicology data, safety data, and efficacy of danegaptide in non-clinical in vitro as well as in vivo trials, Breye demonstrates the significant potential of the active pharmaceutical ingredient in addressing the core pathological events in DR at earlier stages of disease progression, including cell-cell uncoupling, apoptotic vascular cell death, and vascular leakage. Now, the phase 1b/2a clinical trial is designed as an open-label, multicenter, dose-escalating trial to evaluate the drug tolerance, safety, pharmacokinetics (PK), and early signs of biological activity following oral administration of danegaptide in participants diagnosed with DME.

The study’s design is a multicenter, open-label, dose-escalating Phase 1b/2a study to assess the safety, tolerability, pharmacokinetics (PK), and biological effects of orally administered danegaptide in participants diagnosed with DME. While expressing the importance of this clinical trial phase, the CEO of Breye Therapeutics, Ulrik Mouritzen, said, “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. The burden on patients with diabetic retinopathy is significant, and those who experience vision loss and blindness face threats to their physical and mental health and overall quality of life. At Breye, we are committed to helping treat the disease earlier by offering effective oral therapies, to patients who currently have limited or no treatment options.”

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