Oxurion has enrolled the first patient in a Phase l trial examining the safety of THR-687 for the treatment of patients with diabetic macula edema (DME).
The open-label, multicentre, dose-escalation trial intends to study a single intravitreal injection of THR-687 for DME patients.
The trial aims to enrol as many as 18 patients. Its primary endpoint includes the incidence of dose-limiting toxicities, while the secondary endpoints comprise incidence of systemic and ocular adverse events, including serious adverse events, and occurrence of laboratory abnormalities.
Oxurion CEO Patrik De Haes said: “This is an important step in the clinical development of THR-687 and in establishing the safety profile of this pan integrin antagonist in patients with DME.
“This trial initiation follows the recent start of the Phase 1 clinical trial with THR-149 (PKal inhibitor), and the initiation of a Phase 2 with THR-317 (anti-PlGF) in combination with ranibizumab (Lucentis) in April, both for patients with DME.
“Our portfolio of comprehensive drug candidates addresses the clear unmet medical need for improved treatment options for this fast-growing diabetic eye disease market.”
THR-687 is a new pan-RGD integrin antagonist that is being investigated as a potential treatment for patients with diabetic eye disease.
Various preclinical studies have showed the potential of THR-687’s in addressing several aspects of retinal vascular disease such as vessel leakage, inflammation, and neovascularisation.
Macular edema is caused by abnormal leakage and accumulation of fluid in macula, an area in the centre of the retina, from damaged blood vessels in the nearby retina.