Kodiak stock falls after Phase 3 data for lead asset
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Kodiak Sciences (NASDAQ:KOD) announced Monday that its Phase 3 GLOW study for its lead candidate, tarcocimab tedromer, for a form of diabetic eye disease, reached its main goals with statistical significance.
However, citing discussions with the U.S. FDA, the company said it will conduct one more pivotal study to support a marketing application for the candidate.
The plan is to support one Biologics License Application for tarcocimab tedromer in macular edema following retinal vein occlusion (RVO), wet age-related macular degeneration (wAMD), and GLOW’s target, non-proliferative diabetic retinopathy (NPDR).
The shares of the Palo Alto, California-based biotech lost ~8% after the announcement.
Last summer, Kodiak (KOD) paused further studies on tarcocimab after its GLEAM and GLIMMER trials in diabetic macular edema (DME) failed and as the company wanted to further analyze data from GLOW and its pivotal BEACON study in RVO.
As for the GLOW study, the company said NPDR patients who received an every 24-week dosing regimen of tarcocimab indicated at least a 2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) score versus those on control arm, meeting the trial’s primary goal.
The trial also met all key secondary endpoints, such as those related to sight-threatening complications and DME.
In terms of safety, patients in on-drug and off-drug arms showed similar rates of serious ocular adverse events and intraocular inflammation.
