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Clinical Trials

Date: 2018-05-25

Type of information: Recruitment of the first patient

phase: 1

Announcement: recruitment of the first patient

Company: Thrombogenics (Belgium)

Product: THR-149

Action mechanism:

  • kallikrein inhibitor/peptide. THR-149 is a novel plasma kallikrein inhibitor. This bicyclic peptide (Bicycle®) has been identified as a lead candidate in the alliance between ThromboGenics and Bicycle Therapeutics. Bicycles are a novel class of small molecule medicines designed to overcome many of the limitations of existing drug modalities. They can be used as standalone therapeutic entities or coupled to deliver a variety of therapeutic payloads, and exhibit the affinity and exquisite target specificity usually associated with antibodies but in a small molecule format enabling rapid tissue penetration and flexible routes of administration.

Disease: diabetic macular edema

Therapeutic area: Ophtalmological diseases

Country: USA

Trial details:

  • This study is conducted to evaluate the safety of a single intravitreal injection of THR-149. (NCT03511898)

Latest news:

  • • On May 25, 2018, ThromboGenics 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 . 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.
 

Is general: Yes