TLDR
- Kodiak Sciences’ GLOW2 Phase 3 study of Zenkuda met its primary endpoint for treating diabetic retinopathy
- 62.5% of Zenkuda-treated patients hit the target improvement vs. just 3.3% in the sham group
- Zenkuda cut the risk of sight-threatening complications by 85% vs. sham through Week 48
- No cases of intraocular inflammation were reported in the trial
- Kodiak now plans to accelerate its Biologics License Application submission for Zenkuda
Kodiak Sciences (KOD) stock rose to $22.75 following the news, extending a 656% gain over the past year, though the stock remains down 18.6% year-to-date.
Kodiak Sciences reported that its GLOW2 Phase 3 study of Zenkuda (tarcocimab tedromer) met its primary endpoint in treating diabetic retinopathy.
The results, released March 26, showed strong improvement over sham in every measured area.
In the trial, 62.5% of patients treated with Zenkuda achieved a two-step or greater improvement in diabetic retinopathy severity score (DRSS) at Week 48. Just 3.3% of patients in the sham group reached the same mark.
The result was statistically significant, clearing the primary endpoint with high confidence.
Sight-Threatening Complications
Zenkuda also cut the risk of developing prespecified sight-threatening complications by 85% compared to sham through Week 48. Those complications included new or worsening proliferative diabetic retinopathy or center-involving diabetic macular edema.
Only 2.4% of Zenkuda-treated patients developed such complications, versus 15.8% in the sham group.
On the secondary endpoint, 13.7% of Zenkuda patients achieved a three-step or greater improvement in DRSS versus 0% with sham.
These results are consistent with the earlier GLOW1 study, where Zenkuda reduced the risk of sight-threatening complications by 89%.
GLOW2 was designed as a confirmatory study to GLOW1 and expanded the patient population to include those with proliferative diabetic retinopathy and mild diabetic macular edema.
Patients received Zenkuda injections at baseline, Week 4, Week 8, Week 20, and Week 44. All patients were on 6-month dosing by the end of the study.
Safety Profile
The drug’s safety profile held up well. No cases of intraocular inflammation were reported, and no cases of retinal vasculitis or occlusive retinal vasculitis were observed.
The cataract adverse event rate was 2.3% with Zenkuda vs. 1.6% with sham — in line with expected background rates for diabetic retinopathy patients.
GLOW2 also included patients on GLP-1 receptor agonist medications, reflecting a real-world diabetic population. About 46.1% of the Zenkuda arm and 42.4% of the sham arm were on GLP-1 drugs.
Among Zenkuda-treated patients using GLP-1 medications, 60.0% hit the primary endpoint, compared with 64.3% of those not using GLP-1 medications — a small difference that suggests GLP-1 use had little impact on outcomes.
Kodiak said it plans to accelerate its Biologics License Application submission timeline for Zenkuda based on the GLOW2 data.
H.C. Wainwright has a Buy rating on KOD with a $38 price target. UBS also carries a Buy rating with a $50 target.
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