#Denmark #Copenhagen #Diabetic Retinopathy #Breye Therapeutics #danegaptide

Breye Therapeutics Completes Phase 1b Trial of Danegaptide

Breye Therapeutics, a clinical-stage biopharmaceutical company focused on ophthalmologic therapies, has announced the successful completion of its Phase 1b clinical trial featuring danegaptide. This trial specifically targeted patients suffering from non-proliferative diabetic retinopathy (NPDR), a condition that poses a significant risk to vision health in those with diabetes. With millions impacted globally, the significance of developing effective treatment options cannot be overstated.

The Challenge of Diabetic Retinopathy

Diabetic retinopathy is a leading cause of vision impairment worldwide, particularly in individuals with diabetes. Current treatments primarily involve intravitreal injections, which are less favorable for patients due to their invasive nature and associated discomfort. Recognizing the need for non-invasive alternatives, Breye’s approach with danegaptide aims to provide a more acceptable solution for those in the early or moderate stages of this disease.

Danegaptide's Unique Mechanism

Danegaptide is a first-in-class oral small molecule, designed to stabilize ocular vasculature and inhibit cellular disjunction effects caused by elevated glucose levels. By effectively protecting against retinal capillary degeneration and vascular leakage, this innovative therapy holds the promise of mitigating the progression of diabetic retinopathy.

Trial Outcomes and Early Signs of Success

The Phase 1b trial enrolled 24 participants, all of whom tolerated the oral treatment well across various doses. Importantly, no dose-limiting toxicities were observed. The pharmacokinetic data revealed that danegaptide achieved the expected plasma concentrations, confirming preclinical findings. Preliminary clinical response indicators from retinal imaging showed significant reductions in vascular leakage and favorable changes in anatomical parameters, suggesting early therapeutic efficacy.

Ulrik Mouritzen, CEO of Breye Therapeutics, expressed optimism about the results, stating, “These findings underscore danegaptide's potential as a viable, oral, and non-invasive treatment for diabetic retinopathy in earlier stages. As we look towards Phase 2 evaluations, the focus remains on validating our results to align with regulatory standards and ensure patient safety.”

Expert Endorsements

Medical professionals also highlighted the potential impact of danegaptide. Dr. Carl Regillo, Director at Wills Eye Hospital and an advisory board member for Breye, noted how this oral approach could revolutionize the treatment landscape for diabetic eye diseases, particularly for the hundreds of thousands of patients grappling with NPDR.

Looking Ahead: Phase 2 Trials

Breye’s next steps include the initiation of a Phase 2 trial, aimed at a more tailored NPDR patient demographic and utilizing the Diabetes Retinopathy Severity Scale as a regulatory endpoint for advancement. This crucial phase will focus on demonstrating the clinical proof-of-concept that danegaptide can indeed transform treatment perspectives for diabetic retinopathy. Additionally, the company is actively seeking funding to support this advancement through collaboration with investors and stakeholders.

Conclusion

Breye Therapeutics stands at the forefront of a potential breakthrough in diabetic retinopathy management with the innovative danegaptide. As the company prepares for its Phase 2 clinical evaluations, it remains committed to developing effective, safe, and non-invasive treatment options that could fundamentally alter the trajectory of this prevalent eye disease, ultimately preserving vision and enhancing patients' quality of life.

For more information on Breye Therapeutics and their ongoing projects, visit their official website.