Publication date: 25/05/2018
ThromboGenics NV (Euronext Brussels: THR), a biotechnology company developing novel medicines for diabetic eye disease, announces that it has successfully enrolled the first patient in a Phase 1 open-label, multicenter, dose escalation study evaluating the safety of THR-149 in the treatment of DME (NCT03511898).
THR-149 is a novel plasma kallikrein inhibitor generated using Bicycle Therapeutics' Bicycles® technology platform, and the kallikrein-kinin system is considered a valid target for the treatment of DME through inhibition of plasma kallikrein.
Preclinical studies have demonstrated the potency and efficacy of bicyclic peptide inhibitors of PKal, such as THR-149, supporting its progression into clinical trials for the potential treatment of DME, via a VEGF-independent mechanism.
The Phase 1 study (THR-149-001) will primarily assess the safety of a single intravitreal injection of escalating dose levels of THR-149 in patients with DME. Approximately 18 patients will be enrolled.
Initial results from the THR-149-001 study are anticipated in mid-2019.
Susan Schneider, MD, Chief Medical Officer of ThromboGenics, said: "We are pleased to have progressed THR-149 into clinical development by initiating this Phase 1 study. This is a key step in assessing THR-149's safety profile and its potential role in treating DME."
Patrik De Haes, MD, ThromboGenics CEO, commented: "Bringing THR-149 into the clinic marks the achievement of an important milestone in the progression of our pipeline, following the recent start of a Phase 2 with THR-317 in combination with Lucentis® in patients with DME. We also plan to bring THR-687, an integrin antagonist targeting diabetic retinopathy and DME, into the clinic mid-this year. We remain focused on developing all three of these disease-modifying candidates to allow us to generate value from the fast-growing diabetic eye disease market."
ThromboGenics is a biopharmaceutical company focused on developing innovative treatments for diabetic eye disease. The company's pipeline of disease modifying drug candidates is targeting the key segments of the diabetic eye disease market.
ThromboGenics' clinical pipeline consists of THR-317, a PlGF inhibitor, for the treatment of diabetic macular edema (DME), which is in an ongoing Phase 2 clinical study in combination Lucentis®, and THR-149, a plasma kallikrein inhibitor which is in a Phase 1 clinical study for DME. Another candidate, THR-687 (an integrin antagonist) is in late-stage preclinical development for the treatment of diabetic retinopathy and DME. THR-687 is expected to enter the clinic around mid-2018. Further new drug candidates are currently being assessed and developed for the treatment of diabetic eye disease.
ThromboGenics owns the global rights to JETREA® (ocriplasmin), the only pharmacological vitreolysis drug approved for the treatment of symptomatic vitreomacular adhesion (in the US) and vitreomacular traction (outside the US).
ThromboGenics is headquartered in Leuven, Belgium, and is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com