Kodiak Sciences (KOD) Stock Surges as Zenkuda Eye Treatment Achieves Phase 3 Success

Key Highlights

• Zenkuda achieved its primary endpoint in the GLOW2 Phase 3 trial for diabetic retinopathy patients
• Treatment showed 62.5% of patients achieving significant DRSS improvement compared to only 3.3% in control group
• An 85% reduction in sight-threatening complications was observed versus sham treatment at Week 48
• Zero instances of intraocular inflammation were documented during the trial
• Company intends to expedite Biologics License Application filing for Zenkuda

Shares of Kodiak Sciences (KOD) climbed to $22.75 after the announcement, building on a remarkable 656% surge over the previous 12 months, despite trading 18.6% lower since January.

Kodiak Sciences Inc., KOD

Kodiak Sciences announced on March 26 that its GLOW2 Phase 3 clinical trial evaluating Zenkuda (tarcocimab tedromer) successfully achieved its primary endpoint for diabetic retinopathy treatment.

The data demonstrated meaningful superiority over sham treatment across all measured parameters.

Patients receiving Zenkuda treatment showed a two-step or greater improvement in diabetic retinopathy severity score (DRSS) at the 48-week mark in 62.5% of cases. In stark contrast, the sham treatment group achieved this threshold in merely 3.3% of participants.

The findings achieved statistical significance, exceeding the primary endpoint requirements with robust confidence levels.

Reducing Vision-Threatening Events

The treatment demonstrated an impressive 85% reduction in the development of prespecified sight-threatening events when compared to sham through the 48-week period. These serious complications encompassed new-onset or worsening proliferative diabetic retinopathy as well as center-involving diabetic macular edema.

Merely 2.4% of those receiving Zenkuda developed these complications, while 15.8% of the sham group experienced such events.

Regarding secondary endpoints, 13.7% of Zenkuda recipients demonstrated a three-step or greater DRSS improvement, whereas the sham group recorded 0% achievement.

These findings align closely with the preceding GLOW1 trial, which showed Zenkuda reducing sight-threatening complication risk by 89%.

GLOW2 served as a confirmatory trial to GLOW1 and broadened the study population to encompass individuals with proliferative diabetic retinopathy and mild diabetic macular edema.

Participants received Zenkuda injections at baseline, followed by Week 4, Week 8, Week 20, and Week 44. By study completion, all participants had transitioned to a 6-month dosing schedule.

Safety Results

The treatment maintained a favorable safety profile throughout the study. Zero cases of intraocular inflammation were documented, and no instances of retinal vasculitis or occlusive retinal vasculitis were detected.

Cataract adverse events occurred in 2.3% of Zenkuda recipients versus 1.6% in the sham group — rates consistent with typical background occurrence in diabetic retinopathy patient populations.

GLOW2 enrolled patients receiving GLP-1 receptor agonist therapies, mirroring the actual diabetic patient population. Approximately 46.1% of Zenkuda participants and 42.4% of sham participants were utilizing GLP-1 medications.

Within the Zenkuda cohort taking GLP-1 treatments, 60.0% achieved the primary endpoint, while 64.3% of non-GLP-1 users reached this goal — a minimal variance indicating GLP-1 therapy had negligible influence on treatment outcomes.

The company announced plans to expedite its Biologics License Application filing timeline for Zenkuda following these encouraging GLOW2 results.

H.C. Wainwright maintains a Buy rating on KOD stock with a price target of $38. UBS similarly holds a Buy rating with a $50 price objective.

The post Kodiak Sciences (KOD) Stock Surges as Zenkuda Eye Treatment Achieves Phase 3 Success appeared first on Blockonomi.