Clinical Trials

Date: 2018-04-04

Type of information: Results

phase: 2

Announcement: results

Company: Thrombogenics (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).
• In pre-clinical models, anti-PlGF has been shown, in addition to anti-angiogenic and anti-edema properties, to also be anti-inflammatory.
• The product is an ophthalmologic formulation of TB-403, that has been developed by the Swedish biotech Bioinvent. ThromboGenics carries all costs for the development of THR-317 and BioInvent is entitled to five percent of the project's economic value.

Disease: diabetic macular edema

Therapeutic area: Ophtalmological diseases

Country: Czech Republic, Hungary, Slovakia

Trial details:

• This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME). (NCT03071068)

Latest news:

• • On April 4, 2018, ThromboGenics reported topline results from a Phase 1/2, single-masked, multicentre study to evaluate the safety and efficacy of 2 dose levels (4 mg and 8 mg) of THR-317 for the treatment of diabetic macular edema.
• The THR-001 study enrolled a total of 49 patients, and included anti-VEGF naïve patients as well as sub-optimal anti-VEGF responders. Initial data reported are for the anti-VEGF treatment naïve group (n=40) up to Day 90; 30 days after the last intravitreal (IVT) anti-PlGF administration. The primary focus of this study was safety outcomes. THR-317 was safe and well tolerated. No dose-limiting toxicities or relevant safety events were reported at either dose level.
• 30% of the anti-VEGF treatment naïve study subjects treated with THR-317 in the 8mg group showed a > or equal to 15 letter gain from baseline at Day 90 versus 5.3 % in the 4mg group.
• These data support initiation of a next study evaluating THR-317 in combination with an anti- VEGF. Clinical trial is targeted to be initiated in Q2 2018. Final results from the THR-317-001 study are being planned for presentation at an upcoming ophthalmology meeting.
• • On January 10, 2017, ThromboGenics announced the enrollment of the first patients in a Phase II, single-masked, multicenter exploratory study evaluating the safety and efficacy of 2 dose levels of THR-317 for the treatment of diabetic macular edema. The Phase II study will evaluate the safety of 3 intravitreal injections of 2 dose levels of THR-317 (4 mg or 8 mg). The trial will also assess THR-317's ability to improve best-corrected visual acuity (BCVA) and to reduce central retinal thickness in subjects with diabetic macular edema.
• Recent preclinical data evaluating THR-317 (using a research grade anti-PlGF antibody) have confirmed a number of potential advantages of an anti-PlGF antibody for the treatment of DR when compared to the current standard of care. Therefore, ThromboGenics believes that THR-317 could be used as a stand-alone therapy or as an add-on treatment to anti-VEGF medicines, for the treatment of DME or DR The study plans to enroll a total of 50 patients over a period of about 12 months. The first results from the study are expected in Q1 2018. ThromboGenics plans on evaluating THR-317 in additional diabetic retinopathy indications if the current Phase II trial delivers positive results.

Is general: Yes