ThromboGenics Enrolls First Patient in Phase 1 Clinical Study Evaluating THR-149, a plasma kallikrein inhibitor, for treatment of Diabetic Macular Edema (DME)

25 May 2018

ThromboGenics Enrolls First Patient
in Phase 1 Clinical Study Evaluating THR-149,
a plasma kallikrein inhibitor, for treatment of Diabetic Macular Edema (DME)

Leuven, Belgium – ThromboGenics NV 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.”