Breye Therapeutics Completes Phase 1b Trials for Danegaptide in NPDR

Breye Therapeutics announced the successful completion of its Phase 1b clinical trial for danegaptide, an innovative oral therapy aimed at treating non-proliferative diabetic retinopathy (NPDR) and associated diabetic macular edema. This milestone was achieved on June 25, 2025, with the trial being conducted across 11 clinical sites in the United States, Germany, and the United Kingdom, involving 24 patients.

Danegaptide, a first-in-class oral small molecule, is designed to stabilize the retinal vasculature and prevent complications such as retinal capillary breakdown and vascular leakage, which are exacerbated by hyperglycemia—a condition prevalent in diabetes. According to Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, the trial results indicate that danegaptide is well-tolerated, showing no dose-limiting toxicities and early signs of clinical activity. “These results continue to support danegaptide’s potential as an oral, non-invasive therapeutic solution for patients in the earlier stages of diabetic retinopathy,” Mouritzen stated in the company’s press release.

The Phase 1b trial was a multicenter, open-label, dose-escalation study focusing on the safety, tolerability, pharmacokinetics, and preliminary biological activity of danegaptide. Notably, pharmacokinetic data confirmed that targeted levels of danegaptide were successfully achieved, supporting its advancement into further clinical trials. Early imaging results revealed reductions in retinal vascular leakage and improvements in anatomic parameters, suggesting a positive impact on patient outcomes.

Dr. Carl Regillo, Director of Retina Service at Wills Eye Hospital and a member of Breye Therapeutics’ Scientific Advisory Board, remarked, “An oral approach like danegaptide has the potential to fundamentally shift how we treat moderate-to-severe stages of diabetic eye disease.” This sentiment underscores the critical need for alternative therapies, especially considering that current options for early-stage NPDR patients are severely limited. Existing treatments primarily involve intravitreal injections, which can be burdensome and poorly tolerated, leading to low patient compliance.

The significance of this trial lies in its potential to address a treatment gap for patients with early-stage NPDR, a condition affecting millions globally. According to the World Health Organization, diabetes is a leading cause of blindness worldwide, affecting approximately 422 million people as of 2014, with projections suggesting this number could rise in the coming years. Furthermore, the 2021 report from the American Academy of Ophthalmology states that diabetic retinopathy is expected to increase in prevalence, emphasizing the urgency for effective treatments.

Looking ahead, Breye Therapeutics plans to initiate a Phase 2 clinical trial that will evaluate danegaptide in a targeted NPDR patient population. The study will utilize the regulatory endpoint of a ≥2-step improvement on the Diabetic Retinopathy Severity Scale, which will help validate danegaptide’s efficacy and further its development as a viable treatment option. As the healthcare industry continues to seek innovative solutions for complex conditions like diabetic retinopathy, danegaptide represents a promising advancement in the field of ophthalmology.

The completion of the Phase 1b trial marks a crucial step in the ongoing quest for non-invasive therapeutic options that could substantially improve the quality of life for patients suffering from diabetic eye diseases. Breye Therapeutics is committed to its mission of preserving vision for patients before irreversible damage occurs, and the encouraging results of this trial may herald a new era in the treatment of diabetic retinopathy.