Breye Therapeutics Reports Positive Phase 1b Results for Danegaptide, Supporting Progression to Phase 2 in Retinal Vascular Diseases

Copenaghen (Denmark) – Golgi Neurosciences Srl is thrilled to share an update from its portfolio company Breye Therapeutics ApS, a clinical-stage biopharmaceutical company developing novel oral therapies for retinal vascular diseases within ophthalmology.

Danegaptide is a first-in-class, orally administered small molecule with a novel mechanism of action that stabilizes the vasculature and protects against cell-cell uncoupling, retinal capillary breakdown, and vascular leakage caused by hyperglycemia.

In a Phase 1b clinical study with 24 participants, Danegaptide demonstrated a favourable safety profile across all dose levels, with no dose-limiting toxicities observed. Pharmacokinetic analyses verified that the anticipated drug exposure levels were attained, consistent with projections from preclinical research. Preliminary evidence of clinical efficacy was observed as measured by retinal imaging, representing decreased vascular leakage and improvements in retinal structure.

These findings support the continued advancement of danegaptide into Phase 2 clinical evaluation.

For more information, please visit Breye Therapeutics website or Golgi Neurosciences Linkedin page.