Salute e Benessere
Breye Therapeutics announces successful completion of its Phase 1b trial with danegaptide in patients with diabetic retinopathy
Danegaptide is a first-in-class oral small molecule with a novel mode of action, that stabilizes the vasculature and protects from cell-cell uncoupling, retinal capillary breakdown and vascular leakage caused by hyperglycemia.
The orally administered treatment was well tolerated across all dose levels in the 24 patients enrolled, with no dose-limiting toxicities reported. Pharmacokinetic (PK) data confirmed that targeted exposures of danegaptide were reached as guided by preclinical data. Early signs of clinical activity were observed, as measured by retinal imaging outcomes, representing reductions in retinal vascular leakage and improvements in anatomical parameters.
The Phase 1b trial was a multicenter, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics (PK) and early signs of biological activity of danegaptide in patients with NPDR and associated diabetic macular edema (DME), a complication of NPDR. Conducted across 11 clinical sites in the UK, Germany and the US, the study confirmed a favourable safety profile, plasma levels within the targeted therapeutic range and early signs of clinical activity.
A subsequent Phase 2 trial is planned to evaluate danegaptide in a targeted NPDR patient population using the regulatory endpoint of ≥2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS). Breye is actively fundraising to support this next phase of development.
Breye Therapeutics is a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases. Breye is developing a pipeline of oral therapies for diseases of the eye, such as intermediate age-related macular degeneration and glaucoma, so more patients can maintain their sight, autonomy, and quality of life. Its lead candidate, danegaptide, is the first oral drug designed to treat diabetic retinopathy in its earlier stages and has a novel mechanism of action designed to stop and reverse disease progression. It is currently progressing through clinical development, with Phase 1b successfully completed and a Phase 2 trial planned to demonstrate clinical proof-of-concept.
Breye is backed by Novo Holdings and Sound BioVentures, and has received financial support from the BioInnovation Institute, the Danish Growth Foundation (Vækstfonden), and the Danish Innovation Foundation (Innovationsfonden).
For more information, please visit: https://breye.com.
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