Kodiak reboots tarcocimab tedromer development program

Having previously had disappointing results from its investigational drug, Kodiak Sciences (Nasdaq: KOD) yesterday announced that its Phase III GLOW superiority study evaluating tarcocimab tedromer 5mg in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) met its one-year primary endpoint.

"This is the first time that 6-month dosing in all patients succeeded in treating diabetic retinopathy which we believe is a meaningful and clinically relevant achievement," said Dr.J Pablo Velazquez-Martin, senior vice president of clinical sciences at Kodiak Sciences. "We think that the consistency of the data across all endpoints, where tarcocimab significantly improved the diabetic eye disease status and, importantly, significantly prevented sight-threatening complications, is remarkable," The GLOW data reinforce the durability potential of tarcocimab and the antibody biopolymer conjugate platform (ABC Platform) in the management of retinal vascular diseases," he added.

"We think that durability remains the most clinically relevant unmet patient need," said Dr Victor Perlroth, chef executive of Kodiak. "We now have three successful Phase III pivotal studies with tarcocimab tedromer across three different retinal vascular and exudative diseases: wet AMD, RVO and NPDR. In recent discussions with the FDA, which included the GLOW data, we believe we have a clear regulatory pathway requiring one additional positive study to support a single BLA submission for all three indications," continued Dr Perlroth.