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Oxurion NV announced Wednesday the first patient to be dosed in the INTEGRAL phase 2 clinical study evaluating THR-687 as a treatment for patients with DME.
Oxurion NV announced Wednesday the first patient to be dosed in the INTEGRAL phase 2 clinical study evaluating THR-687 as a treatment for patients with diabetic macular edema (DME).
The INTEGRAL study is a randomized, multicenter trial that is the first in which multiple intravitreal injections of THR-687 will be administered in humans, according to a company news release.
INTEGRAL intends to evaluate two parts: two dose levels of THR-687 injections (Part A), and if a success, then assess the efficacy and safety of THR-687 in comparison to aflibercept, for the treatment of DME (Part B).
The company reports that Part A of the study is being conducted in treatment naïve subjects to select the optimal THR-687 dose level to be assessed in Part B.
Part B will be conducted in both treatment naïve and treatment experienced subjects to evaluate the efficacy and safety of THR-687 compared to aflibercept, according to the news release.
The company reports that Part B’s primary efficacy endpoint is the changing in best-corrected visual acuity (BCVA) from baseline to Month 3.
Dose selection decision after Part A is estimated for the first half of 2022, while topline data from Part B to follow in the second half of 2023.
The latest development comes following the positive data from a phase 1, open-label, multi-center, single-dose escalation study assessing safety of THR-687 for DME in the form of a single intravitreal injection of 3 dose levels: 0.4 mg, 1.0 mg, and 2.5 mg.
Results from this study showed THR-687 was safe and well-tolerated.
In addition to DME, THR-687 shows potential as a treatment for wet age-related macular degeneration (AMD) and retinal vein occlusion (RVO).