Belgium-based biopharmaceutical company ThromboGenics has initiated patient enrolment for its Phase II clinical study of THR-317 to treat diabetic macular edema (DME).
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THR-317 (anti-PIGF) has been developed as a recombinant human monoclonal antibody, which targets the receptor-binding site of human placental growth factor (PlGF).
Its mechanism of action involves the reduction of blood vessel leakage, which prevents inflammation in early stage, non-proliferative diabetic retinopathy.
The Phase II study will be conducted as a singlemasked, multicentre exploratory study to test the safety and efficacy of two doses of THR-317 through intravitreal injections to treat DME.
It will also assess the ability of THR-317 to improve best corrected visual acuity (BCVA), as well as minimise central retinal thickness caused by DME.
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By GlobalDataThe trial is expected to enrol 50 patients and will release its result in the first quarter of 2018.
ThromboGenics CEO Dr Patrik De Haes said: “Knowing that 35% of all diabetes patients will in their lives develop some form of diabetic retinopathy (DR), there is a clear unmet medical need and an increasing demand for improved or add-on treatment options.
“We believe that our anti-PlGF antibody THR-317 holds the potential to differentiate and improve current standard of care for this important sight-threatening disease.”
Subject to the result of the currently held clinical trial, the company will further explore THR-317 functionality in addressing other DR indications.
The recently held preclinical trial has established benefits of THR-317 in treating DR.
Image: Eye blood vessels surrounded by hard exudates in a DME patient. Photo: courtesy of National Eye Institute, National Institutes of Health.
