First patient dosed in trial for Breye's oral drug to treat diabetic retinopathy

Breye Therapeutics ApS announced today (January 25) that the first patient has been dosed in a phase 1b/2a clinical trial to investigate danegaptide, following oral administration, in patients suffering from diabetic macular edema (DMA).

The Danish company is a clinical-stage biopharmaceutical company developing new oral therapies for retinal vascular diseases within ophthalmology.

Breye is developing oral ophthalmology drugs to address the need for more effective and less burdensome therapies for millions of patients suffering with deteriorating vision due to diabetic retinopathy (DR) or Age-Related Macular Degeneration (AMD).

While there has been successful development of intravitreally administered products for patients with late-stage disease, Breye says treatment options are currently limited for patients in the early or moderate stages.

Clinical trial for danegaptide

Ulrik Mouritzen, chief executive officer of Breye Therapeutics, said: “The launch of the phase 1b/2a clinical trial for danegaptide represents a significant milestone towards realising our mission of developing more effective, globally accessible orally administered treatment solutions for patients at risk of vision loss and blindness.

“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. At Breye, we are committed to help treat the disease earlier by offering effective oral therapies, to patients who currently have limited or no treatment options.”

As an oral therapy, danegaptide targets the core pathological events in DR, including cell-cell uncoupling, apoptotic vascular cell death and vascular leakage, at earlier stages of disease progression.

With safety data derived from over 500 clinical trial participants, robust toxicology data, and strong non-clinical in vitro and in vivo efficacy results, there is strong support for danegaptide’s potential to address the clinical core ocular pathologies of vascular leakage and capillary breakdown. The positive effects of treating these pathologies have been clinically validated.

The study’s design is a multicenter, open-label, dose-escalating phase 1b/2a study to assess the safety, tolerability, pharmacokinetics (PK), and early signs of biological activity following oral administration of danegaptide in participants diagnosed with DME.

Patients with diabetic retinopathy

Carl Regillo is MD, director of retina service of Wills Eye Hospital and professor of ophthalmology at Thomas Jefferson University in Philadelphia, and member of the Breye therapeutics scientific advisory board.

He said: “Danegaptide has the potential to become a valuable oral treatment option for patients with diabetic retinopathy. Patients should ideally be treated earlier and before the disease progresses to later stages, where laser treatments or intravitreally administered products are required.”

Severe diabetic retinopathy requires intravitreal injections directly into the eye, which are unpopular with patients, resulting in a significant drop out rate of about 50% after one year and only 40% of patients obtain an optimal response. Breye says orally administered drugs will be less burdensome than injections, as well as potentially more effective and commercially competitive.

With its clinically de-risked safety profile, the company says its lead program with danegaptide has potential for a short and well-accepted clinical regulatory pathway. Breye is also developing an oral P2X7R antagonist for AMD which seeks to reduce nerve damage and inflammation.

Breye raised a seed round from Novo Holdings and Sound BioVentures and received financial support from the BioInnovation Institute, the Danish Growth Foundation (Vækstfonden) and the Danish Innovation Foundation (Innovationsfonden).