Date: 2018-09-20
Type of
information: Recruitment of the first patient
phase: 2
Announcement: recruitment of the first patient
Company: Oxurion (Belgium)
Product: THR-317
Action
mechanism:
- monoclonal antibody. THR-317 (anti-PIGF) is a recombinant human monoclonal antibody directed against the receptor-binding site of human placental growth factor (PlGF). The product is an ophthalmologic formulation of TB-403, that has been developed by the swedish biotech Bioinvent.
Disease: macular telangiectasia type 1 (MacTel 1)
Therapeutic
area: Rare diseases - Ophtalmological diseases
Country:
Trial
details:
- This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (CST) and improving best-corrected visual acuity (BCVA) in subjects with macular telangiectasia Type 1 (MacTel 1). (NCT03669393)
Latest
news:
- • On September 20, 2018, Oxurion (formerly known as ThromboGenics) announced that it has enrolled the first patient in a Phase 2 open-label multi-centre study evaluating the efficacy and safety of intravitreal THR-317, an anti-PIGF (human placental growth factor) antibody, for the treatment of Macular Telangiectasia Type 1 (MacTel 1) MacTel 1 is a rare disease that affects the macula and can lead to vision loss. There is currently no cure or effective treatment for MacTel 1.
- This Phase 2 study (THR-317-003 - ) plans to enrol 10 patients with macular edema caused by MacTel 1, who will each receive 3 intravitreal THR-317 injections over a period of 2 months. Efficacy and safety of the therapy will be assessed via functional and anatomic endpoints.
- This clinical trial is being conducted in line with the Oxurion strategy and mission to expand its focus on developing treatments for other back of the eye diseases, in addition to its novel diabetic eye disease pipeline.
Is
general: Yes
