First patient dosed in phase 1b/2a trial of oral danegaptide for diabetic retinopathy
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Breye Therapeutics has begun dosing in its phase 1b/2a trial of oral danegaptide for treatment of diabetic macular edema, according to a company press release.
“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,” Ulrik Mouritzen, MD, Breye’s CEO, said in the release. “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.”
Although intravitreally administered products are available for individuals with late-stage diabetic retinopathy, few options have been developed for those in early or moderate stages of disease, the release stated. Danegaptide is an oral therapy designed to target core pathological events of disease at earlier stages.
According to the release, the multicenter, open-label, dose-escalating trial will assess the safety, tolerability, pharmacokinetics and early signs of biological activity among participants with diabetic macular edema after oral administration of danegaptide.
“Danegaptide has the potential to become a valuable oral treatment option for patients with diabetic retinopathy,” Carl D. Regillo, MD, FACS, FASRS, chief of retina service at Wills Eye Hospital and member of Breye’s scientific advisory board, said in the release. “Patients should ideally be treated earlier and before the disease progresses to later stages, where laser treatments or intravitreally administered products are required.”
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