US-based biotechnology company Kodiak Sciences has dosed the first subjects with diabetic retinopathy (DR) in its Phase III GLOW2 clinical trial of tarcocimab tedromer.
The randomised, multi-centre trial will assess the efficacy and safety of tarcocimab tedromer in treatment-naïve DR patients.
Patients are being randomised at a 1:1 ratio to receive intravitreal injections of tarcocimab tedromer at baseline, week four, week eight, week 20 and week 44.
The proportion of eyes showing an improvement of at least two steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at week 48 is the trial’s primary endpoint.
Further outcome measures will assess the proportion of eyes that develop sight-threatening complications of DR and the proportion of eyes improving by three or more steps on the DRSS from baseline at week 48.
Kodiak Sciences aims to finish enrolling subjects in the study by the end of this year.
If successful, the trial could help the company secure a marketing authorisation application for tarcocimab tedromer.
The GLOW2 trial's study design is similar to that of the previous GLOW1 study, which found an 89% reduction in the risk of sight-threatening complications among patients treated with tarcocimab tedromer.
Kodiak Sciences CEO Dr Victor Perlroth said: “The GLOW1 data showed unequivocally that treatment with tarcocimab in extended dosing intervals, including six-month dosing in all patients, achieved two related but clinically distinct goals: treating existing disease (primary endpoint of two-step improvement in DRSS) and preventing disease progression (key secondary endpoint of preventing sight-threatening complications).
“This is a key differentiator in the long-acting therapy space, where many therapies are only designed to maintain a patient's current disease status and not to improve it.”
In September last year, Kodiak Sciences released topline results from a Phase III trial of discontinued tarcocimab tedromer in patients with macular oedema caused by retinal vein occlusion.
