Key Takeaways
- Zenkuda achieved its primary goal in Kodiak Sciences’ GLOW2 Phase 3 trial for diabetic retinopathy patients
- Treatment resulted in 62.5% of participants reaching target improvement compared to only 3.3% in the control arm
- The therapy reduced sight-threatening events by 85% versus sham treatment at the 48-week mark
- Zero instances of intraocular inflammation occurred during the study period
- The company will fast-track its regulatory filing for Zenkuda following these results
Shares of Kodiak Sciences (KOD) climbed to $22.75 on the announcement, building on a remarkable 656% climb over the previous 12 months, despite trading 18.6% lower since the start of the current year.
The biotechnology firm disclosed that its GLOW2 Phase 3 clinical study evaluating Zenkuda (tarcocimab tedromer) successfully achieved its primary goal in patients suffering from diabetic retinopathy.
Data unveiled on March 26 demonstrated substantial advantages over the control group across all evaluated metrics.
Within the study population, 62.5% of participants who received Zenkuda experienced a minimum two-step enhancement in their diabetic retinopathy severity score (DRSS) by the 48-week assessment point. In contrast, merely 3.3% of control group participants achieved this same threshold.
The findings reached statistical significance, successfully meeting the primary goal with robust confidence levels.
Prevention of Vision-Threatening Events
Beyond the primary measure, Zenkuda demonstrated an 85% reduction in the likelihood of developing predefined vision-threatening events when compared to the control arm through the 48-week period. These events encompassed new or progressing proliferative diabetic retinopathy or center-involving diabetic macular edema.
A mere 2.4% of participants receiving Zenkuda developed these complications, while 15.8% in the control group experienced them.
Regarding secondary measures, 13.7% of Zenkuda recipients demonstrated a three-step or greater enhancement in DRSS, whereas none of the control group participants reached this milestone.
The findings align with previous data from the GLOW1 investigation, which showed Zenkuda lowered the probability of sight-threatening events by 89%.
GLOW2 served as a confirmatory investigation following GLOW1 and broadened the participant pool to encompass individuals with proliferative diabetic retinopathy and mild diabetic macular edema.
Study participants received Zenkuda administrations at the initial visit, Week 4, Week 8, Week 20, and Week 44. Every participant transitioned to a 6-month treatment schedule by study completion.
Tolerability Data
The treatment demonstrated a favorable tolerability profile throughout the investigation. Zero instances of intraocular inflammation were documented, and no occurrences of retinal vasculitis or occlusive retinal vasculitis were identified.
Cataract-related adverse events occurred in 2.3% of Zenkuda recipients versus 1.6% in the control arm — consistent with anticipated baseline frequencies for diabetic retinopathy populations.
GLOW2 enrolled participants taking GLP-1 receptor agonist therapies, mirroring actual clinical diabetic populations. Approximately 46.1% of the Zenkuda group and 42.4% of the control group were receiving GLP-1 medications.
Within the Zenkuda-treated cohort using GLP-1 therapies, 60.0% achieved the primary measure, versus 64.3% of participants not receiving GLP-1 medications — a minimal variance indicating GLP-1 usage had negligible influence on treatment response.
The company announced it will expedite its Biologics License Application filing schedule for Zenkuda following the GLOW2 outcomes.
H.C. Wainwright maintains a Buy recommendation on KOD shares with a $38 price objective. UBS similarly holds a Buy rating with a $50 target price.
