Danegaptide
Danegaptide has been shown to have an excellent safety profile. Documented in more than 570 human clinical trial subjects and with strong preclinical data in animal models of DR, danegaptide has a short and well accepted clinical regulatory pathway. Oral danegaptide has been tested in a phase 1b clinical trial in patients with DR and macular edema and showed signs of clinical effect. A phase 2 trial in the targeted patient population using the regulatory endpoint ( ≥ 2-step improvement on the diabetic retinopathy severity scale – DRSS) to show clinical proof-of-concept (CPoC) will read-out in 2029.
| Pre-Clinical | Phase 1 | Phase 2 | Phase 3 |
|---|
Danegaptide
Indication: Diabetic Retinopathy
Oral small molecule
P2X7R
Breye is developing an oral P2X7R inhibitor for AMD which seeks to reduce nerve damage and inflammation. Several small molecule drugs which inhibit P2X7 receptors will soon be ready for IND-enabling toxicology studies. These molecules have both anti-inflammatory and neuroprotective effects and literature provides strong support that such molecules will have therapeutic potential in intermediate AMD.
| Lead Optimization | IND Enabling | Phase 1 |
|---|
P2X7R Antagonists
Indication: Intermediate AMD
Oral small molecule
Our Vision is a world where diabetes and AMD do not cause vision loss and blindness
