Key Highlights
- Zenkuda achieved its main objective in the GLOW2 Phase 3 diabetic retinopathy trial conducted by Kodiak Sciences
- Patient response rate reached 62.5% with Zenkuda treatment compared to only 3.3% in the control group
- The drug demonstrated an 85% reduction in vision-threatening complications versus control through 48 weeks
- The study recorded zero instances of intraocular inflammation among participants
- The company is advancing its regulatory submission timeline for Zenkuda based on these findings
Shares of Kodiak Sciences (KOD) climbed to $22.75 on the announcement, building on a remarkable 656% surge over the past 12 months, although the stock still trades 18.6% below its year-to-date starting point.
On March 26, Kodiak Sciences announced that Zenkuda (tarcocimab tedromer) successfully achieved its main objective in the GLOW2 Phase 3 clinical study for diabetic retinopathy.
The data demonstrated superior performance compared to sham treatment across all evaluated metrics.
At the 48-week assessment, 62.5% of participants receiving Zenkuda showed at least a two-step improvement on the diabetic retinopathy severity score (DRSS). In contrast, the sham control group saw only 3.3% of patients reach this threshold.
This outcome achieved statistical significance, successfully meeting the primary objective with robust confidence intervals.
Vision-Threatening Event Reduction
The trial revealed that Zenkuda reduced the occurrence of predefined vision-threatening events by 85% when compared to sham treatment over 48 weeks. These serious events encompassed new or progressive proliferative diabetic retinopathy and center-involving diabetic macular edema.
Among Zenkuda recipients, only 2.4% experienced these complications, while the sham group saw a 15.8% incidence rate.
For the secondary objective, 13.7% of patients on Zenkuda demonstrated three or more steps of improvement on DRSS, while the sham group showed 0% reaching this milestone.
These findings align closely with the preceding GLOW1 trial, which demonstrated an 89% reduction in sight-threatening complications with Zenkuda.
GLOW2 served as a confirmatory study to validate GLOW1 results and broadened enrollment criteria to include individuals with proliferative diabetic retinopathy and mild diabetic macular edema.
The treatment protocol included Zenkuda injections administered at the start, then at Weeks 4, 8, 20, and 44. Every participant transitioned to a 6-month dosing interval by study completion.
Tolerability and Safety Data
The treatment demonstrated a favorable safety record. Zero cases of intraocular inflammation emerged during the trial, and no instances of retinal vasculitis or occlusive retinal vasculitis were documented.
Cataract-related adverse events occurred in 2.3% of Zenkuda-treated patients compared to 1.6% in the sham group — rates consistent with typical background occurrence in diabetic retinopathy populations.
GLOW2 enrollment included patients receiving GLP-1 receptor agonist therapy, creating a study population representative of real-world diabetes treatment. Approximately 46.1% of Zenkuda recipients and 42.4% of sham recipients were taking GLP-1 medications.
Within the Zenkuda group taking GLP-1 drugs, 60.0% achieved the primary endpoint, versus 64.3% among those not using GLP-1 therapy — a modest difference indicating minimal influence of GLP-1 use on treatment response.
The company announced plans to expedite its Biologics License Application filing for Zenkuda following the positive GLOW2 results.
Wall Street analysts at H.C. Wainwright maintain a Buy rating on KOD stock with a $38 price objective. UBS similarly holds a Buy rating with a $50 target price.
