Phase 2 trial for DME treatment fails to meet primary endpoints

Oxurion NV announced top-line results from Part A of its phase 2 trial for THR-687 to treat diabetic macular edema (DME).

Part A data of the INTEGRAL trial found THR-687, an integrin antagonist, to be safe and well-tolerated with no serious adverse effects, according to a news release. Additionally, none of the trial’s participants required rescue medication through Month 3.

However, there was no evidence that was sufficient enough to determine efficacy on the key endpoints: best-corrected visual acuity (BCVA) and central subfield thickness (CST).

Due to these insufficient findings, Oxurion has determined to not advance to Part B of the INTEGRAL trial.

Following this decision, the company will turn its focus to THR-149, which recently indicated a compelling safety and efficacy profile in patients with DME in the first part of the 2-part, phase 2 KALAHARI trial.

INTEGRAL trial background
As a 2-part, randomized, prospective, multicenter trial, INTEGRAL sought to analyze multiple injections of THR-687 in treatment naïve patients diagnosed with DME. Endpoints from Part 1 included safety (n = 16) and efficacy (n = 14), according to the company.

Two doses levels of THR-687 (1.2 mg and 2.0 mg) were each administered in 3 monthly intravitreal injections. Participants are being followed through Month 6 for Part A of the trial.