ThromboGenics NV announced 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.
“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,” Susan Schneider, MD, Chief Medical Officer of ThromboGenics, said in a company news release.
“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,” Patrik De Haes, MD, ThromboGenics CEO, said in the news release. “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.”