Key Takeaways
- The GLOW2 Phase 3 trial of Zenkuda achieved its primary endpoint in diabetic retinopathy treatment
- Treatment with Zenkuda resulted in 62.5% of patients achieving target improvement compared to 3.3% receiving sham
- The drug demonstrated an 85% reduction in sight-threatening complications versus sham by Week 48
- Zero instances of intraocular inflammation occurred during the trial
- The company will move forward with an accelerated Biologics License Application filing
Shares of Kodiak Sciences (KOD) climbed to $22.75 after the announcement, adding to a remarkable 656% surge over the previous twelve months, despite posting an 18.6% decline since the beginning of the current year.
Kodiak Sciences announced positive top-line data from the GLOW2 Phase 3 clinical trial evaluating Zenkuda (tarcocimab tedromer) for diabetic retinopathy.
The March 26 data release demonstrated superior performance across all measured parameters when compared to sham treatment.
Patient data revealed that 62.5% of those receiving Zenkuda experienced two-step or greater improvement on the diabetic retinopathy severity score (DRSS) by Week 48. The sham treatment group saw only 3.3% of participants reach this threshold.
Statistical analysis confirmed the primary endpoint was met with strong significance levels.
Vision-Threatening Event Reduction
The trial showed Zenkuda reduced the incidence of prespecified sight-threatening complications by 85% relative to sham over the 48-week period. These complications encompassed newly developed or worsening proliferative diabetic retinopathy and center-involving diabetic macular edema.
Among Zenkuda recipients, 2.4% experienced such complications, while the sham group recorded a 15.8% rate.
Regarding secondary endpoints, 13.7% of patients treated with Zenkuda demonstrated three-step or greater DRSS improvement, whereas the sham group showed 0% achieving this level.
These findings align with data from the preceding GLOW1 trial, which demonstrated an 89% reduction in sight-threatening complications with Zenkuda.
GLOW2 served as the confirmatory trial for GLOW1, broadening enrollment criteria to include individuals with proliferative diabetic retinopathy and mild diabetic macular edema.
The treatment protocol involved Zenkuda injections administered at baseline, Week 4, Week 8, Week 20, and Week 44. By study completion, all participants had transitioned to 6-month dosing intervals.
Safety Analysis
Safety data from the trial showed favorable tolerability. Zero cases of intraocular inflammation emerged throughout the study period, with no occurrences of retinal vasculitis or occlusive retinal vasculitis documented.
Cataract adverse events occurred at a rate of 2.3% among Zenkuda recipients versus 1.6% in the sham cohort — rates consistent with typical background incidence for diabetic retinopathy patient populations.
GLOW2 enrolled participants taking GLP-1 receptor agonist medications, mirroring contemporary diabetic treatment patterns. Approximately 46.1% of the Zenkuda treatment arm and 42.4% of the sham arm were using GLP-1 drugs.
Among Zenkuda-treated participants on GLP-1 medications, 60.0% achieved the primary endpoint, while 64.3% of those without GLP-1 medication use reached the same milestone — a minimal variance indicating GLP-1 therapy had negligible effect on treatment response.
The company announced plans to expedite its Biologics License Application submission schedule for Zenkuda following these GLOW2 results.
H.C. Wainwright maintains a Buy rating on KOD shares with a $38 price objective. UBS similarly holds a Buy rating with a $50 price target.
