ThromboGenics NV, an integrated biopharmaceutical company, focused on developing novel medicines for diabetic eye disease, announces the enrollment of the first patients in a phase II, single-masked, multicenter exploratory study evaluating the safety and efficacy of 2 dose levels of THR-317 for the treatment of diabetic macular edema (DME).
THR-317 (anti-PIGF) is a recombinant human monoclonal antibody directed against the receptor-binding site of human placental growth factor (PlGF).
The phase II study will evaluate the safety of 3 intravitreal injections of 2 dose levels of THR-317 (4 mg or 8 mg). The trial will also assess THR-317's ability to improve best-corrected visual acuity (BCVA) and to reduce central retinal thickness in subjects with DME.
Recent preclinical data evaluating THR-317 (using a research grade anti-PlGF antibody) have confirmed a number of potential advantages of an anti-PlGF antibody for the treatment of DR when compared to the current standard of care. Therefore, ThromboGenics believes that THR-317 could be used as a stand-alone therapy or as an add-on treatment to anti-VEGF medicines, for the treatment of DME or DR.
The study plans to enroll a total of 50 patients over a period of about 12 months. The first results from the study are expected in Q1 2018.
Dr Patrik De Haes, CEO of ThromboGenics nv, 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. We are very pleased to see the first patients being recruited."
Dr András Seres, ophthalmologist and director at/of Budapest Retina Associates comments, "The pre-clinical data I have seen highlight this anti-PlGF antibody's potential advantages over the current standard of care in DR. With clinicians and patients in need of additional safe and effective therapies for the treatment of DR, these data provide strong rationale for taking the compound into the clinic."
ThromboGenics plans on evaluating THR-317 in additional DR indications if the current phase II trial delivers positive results.