Danegaptide has been shown to have an excellent safety profile. Documented in more than 500 human clinical trial subjects and with strong preclinical data in animal models of DR, danegaptide has a short and well accepted clinical regulatory pathway. This therapy is ready to be tested in a phase 1b clinical trial in patients with DR having macular edema and Breye has designed a subsequent 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) by 2026.
| Lead Optimization | IND Enabling | Phase 1 |
|---|
Indication: Diabetic Retinopathy / Wet AMD
Oral small molecule
Breye is also 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 both in dry AMD and early DR.
| Lead Optimization | IND Enabling | Phase 1 |
|---|
Indication: Dry AMD
Oral small molecule
